NIDEK CO.,LTD.

Address:34-14 MAEHAMA, HIROISHI-CHO,GAMAGORI, AICHI,JP

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Device Description : The Binocular Indirect Ophthalmoscope (hereafter called BIO) delivery unit is co The Binocular Indirect Ophthalmoscope (hereafter called BIO) delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, Model MC-500 (main body), to comprise the photocoagulation system and applied to the treatment of the affected area using the BIO delivery unit (HEINE OMEGA 500). The comprised photocoagulation system allows the operator to select between thermal photocoagulation with the multicolor laser beam (treatment beam) (wavelength: green (532 nm), yellow (577 nm), and red (647nm)) and observation with the BIO.

Device Class : 2

Duns Number: 690635461

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1

Device Description : This delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, M This delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, Model MC-500 main body, to comprise the photocoagulation system and to treat affected areas using the slit lamp, Carl Zeiss Meditec 30 SL/M. This delivery unit is mainly comprised of the delivery unit, protective filter unit, and the split illumination mirror unit. This photocoagulation system allows the operator to select among photocoagulation with the red (647 nm), yellow (577 nm), or green (532 nm) laser beam and observation of the affected area with the slit lamp. This delivery unit can be attached only to the Carl Zeiss Meditec 30 SL/M.

Device Class : 2

Duns Number: 690635461

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1

Device Description : This delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, M This delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, Model MC-500 main body to comprise the photocoagulation system and to treat affected areas using the slit lamp, NIDEK SL-1800/SL-1600. A slit lamp delivery unit that includes the SL-1800 comprises a photocoagulation system in connection with the MC-500 main body. A attachable delivery unit is mainly comprised of a photocoagulation unit and a protective filter unit.They are attached to the NIDEK SL-1800/SL-1600 slit lamp for lasers to comprise a slit lamp delivery unit. The comprised slit lamp delivery unit is connected to the MC-500 to comprise a photocoagulation system. A photocoagulation system allows the operator to select among photocoagulation with the red (647 nm), yellow (577 nm), or green (532 nm) laser beam and observation of the affected area with the slit lamp.

Device Class : 2

Duns Number: 690635461

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1

Device Description : The attachable delivery unit is attached to the Carl Zeiss Meditec SL 130 (herea The attachable delivery unit is attached to the Carl Zeiss Meditec SL 130 (hereafter called Zeiss SL 130) to comprise a slit lamp delivery unit. The comprised slit lamp delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, Model MC-500 to comprise a photocoagulation system.The photocoagulation system allows the operator to select among photocoagulation with the red (647 nm), yellow (577 nm), or green (532 nm) laser beam and observation of the affected area with the slit lamp. The attachable delivery unit is mainly comprised of a photocoagulation unit, a protective filter unit, and a split mirror illumination unit.

Device Class : 2

Duns Number: 690635461

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1

Device Description : The attachable delivery unit is attached to the Carl Zeiss 30SL/M (hereafter cal The attachable delivery unit is attached to the Carl Zeiss 30SL/M (hereafter called Zeiss 30SL/M) to comprise a slit lamp delivery unit. The comprised scan slit lamp delivery unit is connected to the MC-500 to comprise a photocoagulation system. The photocoagulation system allows the operator to select among photocoagulation with the red (647 nm), yellow (577 nm), or green (532 nm) laser beam and observation of the affected area with the slit lamp. The attachable delivery unit is mainly comprised of a photocoagulation unit, a protective filter unit, and a split mirror illumination unit.

Device Class : 2

Duns Number: 690635461

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1

Device Description : This delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, M This delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, Model MC-500 main body to comprise the photocoagulation system and to treat affected areas using the slit lamp, NIDEK SL-1800/SL-1600. A scan attachable delivery unit is mainly comprised of a photocoagulation unit and a protective filter unit. They are attached to the NIDEK SL-1800/SL-1600 slit lamp for lasers to comprise a scan slit lamp delivery unit. The comprised scan slit lamp delivery unit is connected to the MC-500 to comprise a photocoagulation system. A photocoagulation system allows the operator to select among photocoagulation with the red (647 nm), yellow (577 nm), or green (532 nm) laser beam and observation of the affected area with the slit lamp.

Device Class : 2

Duns Number: 690635461

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1

Device Description : The scan attachable delivery unit is mainly comprised of a photocoagulation unit The scan attachable delivery unit is mainly comprised of a photocoagulation unit and a protective filter unit. They are attached to the Carl Zeiss Meditec SL 130 (Zeiss SL 130) to comprise a scan slit lamp delivery unit. The comprised scan slit lamp delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, Model MC-500 to comprise a photocoagulation system. The photocoagulation system allows the operator to select among photocoagulation with the red (647 nm), yellow (577 nm), or green (532 nm) laser beam and observation of the affected area with the slit lamp.

Device Class : 2

Duns Number: 690635461

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1

Device Description : The scan attachable delivery unit is mainly comprised of a photocoagulation unit The scan attachable delivery unit is mainly comprised of a photocoagulation unit and a protective filter unit. They are attached to the HAAG 900BQ slit lamp to comprise a scan slit lamp delivery unit. The comprised scan slit lamp delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator,Model MC-500 main body to comprise the photocoagulation system. A photocoagulation system allows the operator to select among photocoagulation with the red (647 nm), yellow (577 nm), or green (532 nm) laser beam and observation of the affected area with the slit lamp.

Device Class : 2

Duns Number: 690635461

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1

Device Description : This delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, M This delivery unit is connected to the NIDEK Multicolor Laser Photocoagulator, Model MC-500 main body to comprise the photocoagulation system and to treat affected areas using the slit lamp, NIDEK SL-1800/SL-1600. A scan slit lamp delivery unit that includes the SL-1800 comprises a photocoagulation system in connection with the MC-500 main body. A scan attachable delivery unit is mainly comprised of a photocoagulation unit and a protective filter unit. They are attached to the NIDEK SL-1800/SL-1600 slit lamp for lasers to comprise a scan slit lamp delivery unit. The comprised scan slit lamp delivery unit is connected to the MC-500 to comprise a photocoagulation system. A photocoagulation system allows the operator to select among photocoagulation with the red (647 nm), yellow (577 nm), or green (532 nm) laser beam and observation of the affected area with the slit lamp.

Device Class : 2

Duns Number: 690635461

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1

Device Description : The GREEN LASER PHOTOCOAGULATOR SYSTEM GYC-1000 is an ophthalmological photocoag The GREEN LASER PHOTOCOAGULATOR SYSTEM GYC-1000 is an ophthalmological photocoagulation system using a solid state laser (green laser beam) with a wavelength of 532nm. Like conventional laser photocoagulation systems, this system is used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.Since the GYC-1000 uses a diode laser as its pumping light source, the efficient oscillation of the 532nm laser beam can be obtained. As the GYC-1000 can be used with various kinds of delivery units, the system can be applied to transpupillary photocoagulation using the slit lamp or indirect ophthalmoscope, and to intraocular photocoagulation using the endophotocoagulation probe.

Device Class : 2

Duns Number: 690635461

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1