| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 08809447652016 | PICOPLUS 220V | GEX | Powered Laser Surgical Instrument | 2 | PICOPLUS | ||
| 2 | 08809447654010 | Wire Remote Interlock Key | Wire Remote Interlock Key | GEX | Powered Laser Surgical Instrument | 2 | LaseMD Ultra | |
| 3 | 08809447653990 | LaseMD Ultra | Optic_Goggle (Doctor) | GEX | Powered Laser Surgical Instrument | 2 | LaseMD Ultra | |
| 4 | 08809447652207 | AC POWER CABLE | AC POWER CABLE 3m (GENIUS) | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | N/A | |
| 5 | 08809447653204 | LaseMD Ultra U120V case | LaseMD Ultra U120V case | GEX | Powered Laser Surgical Instrument | 2 | LaseMD Ultra | |
| 6 | 08809447653198 | Incubator cover | cap_incubator | GEX | Powered Laser Surgical Instrument | 2 | LaseMD Ultra | |
| 7 | 08809447653181 | Metal goggle/Spring | Patient goggle | GEX | Powered Laser Surgical Instrument | 2 | LaseMD Ultra | |
| 8 | 08809447653150 | AC POWER CABLE | AC POWER CABLE 3m | GEX | Powered Laser Surgical Instrument | 2 | LaseMD Ultra | |
| 9 | 08809447653143 | Foot Switch | Foot Switch | GEX | Powered Laser Surgical Instrument | 2 | LaseMD Ultra | |
| 10 | 08809447653136 | LaseMD Ultra Operator's Manual for USA | LaseMD Ultra Operator's Manual for USA | GEX | Powered Laser Surgical Instrument | 2 | LaseMD Ultra | |
| 11 | 08809447653129 | Handpiece stand Assy | Handpiece stand | GEX | Powered Laser Surgical Instrument | 2 | LaseMD Ultra | |
| 12 | 08809447653112 | Handpiece holder | Handpiece holder | GEX | Powered Laser Surgical Instrument | 2 | LaseMD Ultra | |
| 13 | 08809447653105 | Handpiece | HANDPIECE ASSY_LaseMD Ultra | GEX | Powered Laser Surgical Instrument | 2 | LaseMD Ultra | |
| 14 | 08809447653099 | ASSY_TIP_C5 | ASSY_TIP_C5 | GEX | Powered Laser Surgical Instrument | 2 | LaseMD Ultra | |
| 15 | 08809447653082 | BLISTERED COMB SET_LaseMD Ultra | BLISTERED COMB SET_LaseMD Ultra | GEX | Powered Laser Surgical Instrument | 2 | LaseMD Ultra | |
| 16 | 08809447653075 | BLISTERED SQUARE SET_LaseMD Ultra | BLISTERED SQUARE SET_LaseMD Ultra | GEX | Powered Laser Surgical Instrument | 2 | LaseMD Ultra | |
| 17 | 08809447653068 | BLISTERED ROLLER SET_LaseMD Ultra | BLISTERED ROLLER SET_LaseMD Ultra | GEX | Powered Laser Surgical Instrument | 2 | LaseMD Ultra | |
| 18 | 08809447653044 | LaseMD Ultra U120V | LaseMD Ultra U120V | GEX | Powered Laser Surgical Instrument | 2 | LaseMD Ultra | |
| 19 | 08809447652412 | Spectra Lotion for KSA | Spectra Lotion for KSA(Kingdom of Saudi Arabia) | GEX | Powered Laser Surgical Instrument | 2 | N/A | |
| 20 | 08809447652290 | Handpiece Holder | Handpiece Holder (Accessary) | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | N/A | |
| 21 | 08809447652283 | HANDPIECE_LUTRONIC GENIUS | HANDPIECE ASSY_LUTRONIC GENIUS | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | N/A | |
| 22 | 08809447652276 | G49D TIP(200, 0.5) Lutronic GENIUS | G49D TIP(200, 0.5) Lutronic GENIUS (멸균) | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | N/A | |
| 23 | 08809447652252 | Lutronic Genius Operator's Manual USA | Lutronic Genius Operator's Manual USA | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | N/A | |
| 24 | 08809447652214 | Handpiece cradle | Handpiece cable hanger | GEI | Electrosurgical, Cutting & Coagulation & Accessories | N/A | ||
| 25 | 08809447652191 | Metal Goggle (for patient) | Metal Goggle (for patient) of Advantage/Eco2/ACTIONII/SPECTRA/CLARITY/ LASEMD/ D Metal Goggle (for patient) of Advantage/Eco2/ACTIONII/SPECTRA/CLARITY/ LASEMD/ DENTAII / PICOPLUS | GEX | Powered Laser Surgical Instrument | 2 | N/A | |
| 26 | 08809447652184 | Operator's Goggle | Operator's Goggle for CLARITY/ADVANTAGE | GEX | Powered Laser Surgical Instrument | 2 | N/A | |
| 27 | 08809447652177 | Operator's Goggle | Operator's Goggle for DENTA II | ONG | Powered Laser Surgical Instrument With Microbeam\Fractional Output | 2 | N/A | |
| 28 | 08809447652160 | Operator's Goggle | Operator's Goggle for LASEMD/ACTION II | GEX | Powered Laser Surgical Instrument | 2 | N/A | |
| 29 | 08809447652153 | LUT FILTER Goggle (for Operator) | LUT FILTER Goggle (for Operator) for SPECTRA/PICOPLUS | GEX | Powered Laser Surgical Instrument | 2 | N/A | |
| 30 | 08809447652146 | Operator's Goggle (532/1064nm) | Operator's Goggle (532/1064nm) for SPECTRA & PICOPLUS | GEX | Powered Laser Surgical Instrument | 2 | N/A | |
| 31 | 08809447652139 | Patient Goggle | Patient Goggle for INFINI | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | N/A | |
| 32 | 08809447652108 | PICOPLUS ARM | PICOPLUS ARM | GEX | Powered Laser Surgical Instrument | 2 | N/A | |
| 33 | 08809447652061 | PICOPLUS Operator's Manual (ENG, US) | PICOPLUS Operator's Manual (ENG, US) | GEX | Powered Laser Surgical Instrument | 2 | N/A | |
| 34 | 08809447652054 | Pico Toning Collimated Handpiece (6-10mm) | Pico Toning Collimated Handpiece (6-10mm) | GEX | Powered Laser Surgical Instrument | 2 | N/A | |
| 35 | 08809447652047 | Zoom Handpiece (1-6mm) | Zoom Handpiece (1-6mm) | GEX | Powered Laser Surgical Instrument | 2 | N/A | |
| 36 | 08809447652009 | LASEMD Operator's Manual for USA | LASEMD Operator's Manual for USA | GEX | Powered Laser Surgical Instrument | 2 | N/A | |
| 37 | 08809447651996 | BLISTERED COMB SET | BLISTERED COMB SET | GEX | Powered Laser Surgical Instrument | 2 | N/A | |
| 38 | 08809447651989 | BLISTERED SQUARE SET | BLISTERED SQUARE SET | GEX | Powered Laser Surgical Instrument | 2 | N/A | |
| 39 | 08809447651972 | BLISTERED ROLLER SET | BLISTERED ROLLER SET | GEX | Powered Laser Surgical Instrument | 2 | N/A | |
| 40 | 08809447651941 | TIP 9X9 | Action II TIP 9x9 (Fractional TIP) | GEX | Powered Laser Surgical Instrument | 2 | N/A | |
| 41 | 08809447651934 | ACTIONII Operator's Manual for USA | ACTIONII Operator's Manual for USA | GEX | Powered Laser Surgical Instrument | 2 | N/A | |
| 42 | 08809447651927 | Petit 360 Handpiece | Petit 360 Handpiece | GEX | Powered Laser Surgical Instrument | 2 | N/A | |
| 43 | 08809447651910 | PETIT 90 Handpiece | PETIT 90 Handpiece | GEX | Powered Laser Surgical Instrument | 2 | N/A | |
| 44 | 08809447651903 | SHININGPEEL Handpiece | Shiningpeel Handpiece | GEX | Powered Laser Surgical Instrument | 2 | N/A | |
| 45 | 08809447651897 | ARRAY Handpiece | Array Handpiece (Fractional Handpiece) | GEX | Powered Laser Surgical Instrument | 2 | N/A | |
| 46 | 08809447651880 | 1-7 Zoom Handpiece | Action II 1-7mm Zoom Handpiece (Zoom Handpiece) | GEX | Powered Laser Surgical Instrument | 2 | N/A | |
| 47 | 08809447651859 | ACTIONII ARM | ActionII ARM (Articulated ARM) | GEX | Powered Laser Surgical Instrument | 2 | N/A | |
| 48 | 08809447651781 | TIP A-49 1 ea | INFINI MFR TIP A-49 1 ea(MFR 49 Tip) | GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | N/A | |
| 49 | 08809447651729 | Arm | Healite II Arm(Arn) | ILY | Lamp, Infrared, Therapeutic Heating | 2 | N/A | |
| 50 | 08809447651712 | Manual | Healite II Manual(Operator's Manual) | ILY | Lamp, Infrared, Therapeutic Heating | 2 | N/A |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 08800077100045 | D478000 | SMARTLUX MINI is the combination of low power beam irradiator and infrared irrad SMARTLUX MINI is the combination of low power beam irradiator and infrared irradiator, and it is KGMP, CE/MDD class IIa class medical equipment. Your attention to prevent danger or injury is required. Please read User’s Manual carefully before you use medical equipment, and if you have any questions on safety, application, or operation of the equipment, please contact MEDMIX Co., Ltd. or its distributor. | Medmix | MEDMIX CO., LTD. | |
| 2 | 08057949171645 | LUMIX C.P.S. 3 | LUMIXQ01 | LASER THERAPY UNIT LUMIX Q with 2 WAVELENGTH (650nm+1064nm) | LUMIX Q | FISIOLINE SRL |
| 3 | 08057949171553 | LUMIX ULTRA 2 | LULTRA1901HP | LASER THERAPY UNIT LUMIX ULTRA/PLUS with 4 WAVELENGTH (650nm+810nm+910nm+1064nm) LASER THERAPY UNIT LUMIX ULTRA/PLUS with 4 WAVELENGTH (650nm+810nm+910nm+1064nm) version HP | LUMIX ULTRA/PLUS | FISIOLINE SRL |
| 4 | 08057949170402 | LUMIX ULTRA 3 | LPLUS1602 | LASER THERAPY UNIT LUMIX ULTRA/PLUS with 4 WAVELENGTH (650nm+810nm+910nm+980nm) | LUMIX ULTRA/PLUS | FISIOLINE SRL |
| 5 | 08057949170396 | LUMIX ULTRA 2 | LPLUS1601 | LASER THERAPY UNIT LUMIX ULTRA/PLUS with 4 WAVELENGTH (650nm+810nm+910nm+1064nm) | LUMIX ULTRA/PLUS | FISIOLINE SRL |
| 6 | 08057949170389 | LUMIX ULTRA 1 | LPLUS13 | LASER THERAPY UNIT LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910mn+1064nm) | LUMIX ULTRA/PLUS | FISIOLINE SRL |
| 7 | 08057949170372 | LUMIX ULTRA 3 | LPLUS1002 | LASER THERAPY UNIT LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910nm+980nm) | LUMIX ULTRA/PLUS | FISIOLINE SRL |
| 8 | 08057949170365 | LUMIX ULTRA 1 | LPLUS1001 | LASER THERAPY UNIT LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910nm+1064nm) | LUMIX ULTRA/PLUS | FISIOLINE SRL |
| 9 | 08057949170358 | LUMIX ULTRA 1 | LULTRA35 | LASER THERAPY LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910nm+1064nm) | LUMIX ULTRA/PLUS | FISIOLINE SRL |
| 10 | 08057949170341 | LUMIX ULTRA 1 | LULTRA21 | LASER THERAPY UNIT LUMIX ULTRA/PLUS with 3 WAVELENGTH (650nm+910nm+1064nm) | LUMIX ULTRA/PLUS | FISIOLINE SRL |
| 11 | 08057949170334 | LUMIX ULTRA 3 | LULTRA1902 | LASER THERAPY UNIT LUMIX ULTRA/PLUS with 4 WAVELENGTH (650nm+810nm+910nm+980nm) | LUMIX ULTRA/PLUS | FISIOLINE SRL |
| 12 | 08057949170327 | LUMIX ULTRA 2 | LULTRA1901 | LASER THERAPY UNIT LUMIX ULTRA/PLUS with 4 WAVELENGTH (650nm+810nm+910nm+1064nm) | LUMIX ULTRA/PLUS | FISIOLINE SRL |
| 13 | 08057949170167 | LUMIX C.P.S.3 | LCPS31 | LASER THERAPY UNIT LUMIX C.P.S. with 3 WAVELENGTH (650nm+910nm+1064nm) | LUMIX C.P.S. | FISIOLINE SRL |
| 14 | 08057949170150 | LUMIX C.P.S.3 | LCPS17 | LASER THERAPY UNIT LUMIX C.P.S. with 3 WAVELENGTH (650nm+910nm+1064nm) | LUMIX C.P.S. | FISIOLINE SRL |
| 15 | 08057949170143 | LUMIX C.P.S.5 | LCPS1502 | LASER THERAPY UNIT LUMIX C.P.S. with 4 WAVELENGTH (650nm+810nm+910nm+1064nm) | LUMIX C.P.S. | FISIOLINE SRL |
| 16 | 08057949170136 | LUMIX C.P.S.4 | LCPS1501 | LASER THERAPY UNIT LUMIX C.P.S. with 4 WAVELENGTH (650nm+810nm+910nm+980nm) | LUMIX C.P.S. | FISIOLINE SRL |
| 17 | 08057949170129 | LUMIX C.P.S.3 | LCPS12 | LASER THERAPY UNIT LUMIX C.P.S. with 3 WAVELENGTH (650nm+910nm+1064nm) | LUMIX C.P.S. | FISIOLINE SRL |
| 18 | 08057949170112 | LUMIX C.P.S.3 | LCPS902 | LASER THERAPY UNIT LUMIX C.P.S. with 3 WAVELENGTH (650nm+910nm+1064nm) | LUMIX C.P.S. | FISIOLINE SRL |
| 19 | 08057949170105 | LUMIX C.P.S.2 | LCPS901 | LASER THERAPY UNIT LUMIX C.P.S. with 3 WAVELENGTH (650nm+910nm+980nm) | LUMIX C.P.S. | FISIOLINE SRL |
| 20 | 08057949170099 | LUMIX C.P.S.1 | LCPS702 | LASER THERAPY UNIT LUMIX C.P.S. with 3 WAVELENGTH (650nm+810nm+910nm) | LUMIX C.P.S. | FISIOLINE SRL |
| 21 | 08057949170082 | LUMIX C.P.S.4 | LCPS701 | LASER THERAPY UNIT LUMIX C.P.S. with 4 WAVELENGTH (650nm+810nm+910nm+980nm) | LUMIX C.P.S. | FISIOLINE SRL |
| 22 | 08057949170075 | LUMIX C.P.S.5 | LCPS6 | LASER THERAPY UNIT LUMIX C.P.S. with 4 WAVELENGTH (650nm+810nm+910nm+1064nm) | LUMIX C.P.S. | FISIOLINE SRL |
| 23 | 08057949170068 | LUMIX C.P.S.5 | LCPS5 | LASER THERAPY UNIT LUMIX C.P.S. with 4 WAVELENGTH (650nm+810nm+910nm+1064nm) | LUMIX C.P.S. | FISIOLINE SRL |
| 24 | 08057949170044 | LUMIX 250 | LUMIX250R2 | LASER THERAPY UNIT LUMIX 250 TOUCH SCREEN with 2 WAVELENGTH (650nm+910nm) AVERAGE POWER 5W | LUMIX 250 | FISIOLINE SRL |
| 25 | 08057949170037 | LUMIX 100 | LUMIX100R2 | LASER THERAPY UNIT LUMIX 100 TOUCH SCREEN with 2 WAVELENGTH (650nm+910nm) AVERAGE POWER 2W | LUMIX 100 | FISIOLINE SRL |
| 26 | 08057949170020 | LUMIX 2 | L2PC02 | LASER THERAPY UNIT LUMIX 2 with 2 WAVELENGTH | LUMIX 2 | FISIOLINE SRL |
| 27 | 08057949170013 | LUMIX 2 | L2PC01 | LASER THERAPY UNIT LUMIX 2 TOUCH SCREEN with 2 WAVELENGTH (650nm+910nm) | LUMIX 2 | FISIOLINE SRL |
| 28 | 08057017760498 | M120F1 | M120F1 | The PHYSIQ is a system provided with 4 IR LED to provide topical heating for the The PHYSIQ is a system provided with 4 IR LED to provide topical heating for the purpose of elevating tissue temperature for temporary relief of muscles.A LED mounted on top of each handpiece is lighted when the handpiece is emitting. | DEKA PHYSIQ | EL.EN. SPA |
| 29 | 08057017760214 | M080K1 | M080K1 | The ASA LASER HIRO 3.0 device is a medical device for carrying out therapy in th The ASA LASER HIRO 3.0 device is a medical device for carrying out therapy in the treatment of musculotendinous and joint pathologies with Nd:YAG Laser source. | DEKA HIRO 3.0 | EL.EN. SPA |
| 30 | 08057017760207 | M077H3 | M077H3 | The ASA LASER SH1 device is a medical device for carrying out therapy in the tre The ASA LASER SH1 device is a medical device for carrying out therapy in the treatment of musculotendinous and joint pathologies with Nd:YAG laser sources. | SH1 | EL.EN. SPA |
| 31 | 08033945934347 | PDMS00246 | Hyperblue plus | QUANTA SYSTEM SPA | ||
| 32 | 08033765391207 | F9000258 | The Mphi 7 is an electrically-powered diode laser intended to provide non-surgic The Mphi 7 is an electrically-powered diode laser intended to provide non-surgical infrared laser therapy for localized treatment of musculoskeletal conditions (e.g., muscle/joint pain, sports injury), improving blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. It consists of a control unit which may be mounted on a mobile trolley and one or more connected applicator to delivery of visible/infrared laser light energy. | Mphi 7 | ASA SRL | |
| 33 | 08033765391054 | F9000247 | M8 | ASA SRL | ||
| 34 | 08033765391023 | Mphi D | F9000235 | ASA srl | ASA SRL | |
| 35 | 08033765391016 | Mphi | F9000221 | ASA srl | ASA SRL | |
| 36 | 08033765391009 | M6 | F9000207 | ASA srl | ASA SRL | |
| 37 | 07290016746334 | VRE2003 | VRE2003 | FC Applicator | FC Applicator | VIORA LTD |
| 38 | 07290016746327 | VRE2002 | VRE2002 | BC Applicator | BC Applicator | VIORA LTD |
| 39 | 07290016746310 | VRE2001 | VRE2001 | ST Applicator | ST Applicator | VIORA LTD |
| 40 | 07290016746303 | VRE0110 | VRE0110 | Reaction™ | Reaction™ | VIORA LTD |
| 41 | 07290016681000 | FS10000 | FS10000 | Multi-modality system supporting IPL (Intense Pulsed Light), RF (Radio Frequency Multi-modality system supporting IPL (Intense Pulsed Light), RF (Radio Frequency) and Diamond Peeling applicators for various treatmentssuch as Hair Removal, Acne, Pigmented Lesions, Skin Dermabrasion | Forma | FORMATK SYSTEMS LTD |
| 42 | 06974746830013 | HK209 | NA | NINGBO HESI ELECTRONICS CO., LTD. | ||
| 43 | 06974746830006 | HK207 | NA | NINGBO HESI ELECTRONICS CO., LTD. | ||
| 44 | 06974214160192 | CHERYLAS-20N | Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, a Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K) | Dimed | WUHAN DIMED LASER TECHNOLOGY CO., LTD. | |
| 45 | 06974214160185 | CHERYLAS-15N | Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, a Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K) | Dimed | WUHAN DIMED LASER TECHNOLOGY CO., LTD. | |
| 46 | 06974214160178 | CHERYLAS-60K | Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, a Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K) | Dimed | WUHAN DIMED LASER TECHNOLOGY CO., LTD. | |
| 47 | 06974214160161 | CHERYLAS-70J | Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, a Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K) | Dimed | WUHAN DIMED LASER TECHNOLOGY CO., LTD. | |
| 48 | 06974214160154 | CHERYLAS-60J | Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, a Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K) | Dimed | WUHAN DIMED LASER TECHNOLOGY CO., LTD. | |
| 49 | 06974214160147 | CHERYLAS-30J | Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, a Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K) | Dimed | WUHAN DIMED LASER TECHNOLOGY CO., LTD. | |
| 50 | 06974214160130 | CHERYLAS-70I | Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, a Therapy Laser System, with Product Code of ILY, Regulation number of 890.5500, and exempt from 510(K) | Dimed | WUHAN DIMED LASER TECHNOLOGY CO., LTD. |