Laseroptek Co.,Ltd

Address:Hyundai I valley 114, 116, 117, 203 and 204. 31, Galmachi-ro,Seongnam Gyeonggi,KR

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Powered Laser Surgical Instrument (GEX) (10)

Premarket Exempt

Clear

LOTUS Ⅱ Arm - 08800035500337 Catalog Number :

Device Description : LOTUS Ⅱ Arm

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

LOTUS Ⅱ Zoom Handpiece - 08800035500344 Catalog Number :

Device Description : LOTUS Ⅱ Zoom Handpiece

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

LOTUS Ⅱ Fractional Handpiece - 08800035500351 Catalog Number :

Device Description : LOTUS Ⅱ Fractional Handpiece

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

LOTUS Ⅱ User Manual - 08800035500368 Catalog Number :

Device Description : LOTUS Ⅱ User Manual

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

LOTUS Ⅱ Service Manual - 08800035500375 Catalog Number :

Device Description : LOTUS Ⅱ Service Manual

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

LOTUS Ⅱ Foot Switch - 08800035500382 Catalog Number :

Device Description : LOTUS Ⅱ Foot Switch

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HYPERION body - 08800035500412 Catalog Number :

Device Description : HYPERION body

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HYPERION Arm - 08800035500429 Catalog Number :

Device Description : HYPERION Arm

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HYPERION Gold Handpiece - 08800035500436 Catalog Number :

Device Description : HYPERION Gold Handpiece

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HYPERION Red Handpiece - 08800035500443 Catalog Number :

Device Description : HYPERION Red Handpiece

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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