Laseroptek Co.,Ltd

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

No

Clear

HELIOS Ⅲ body - 08800035500009 Catalog Number :

Device Description : HELIOS Ⅲ body

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HELIOS Ⅲ Arm - 08800035500016 Catalog Number :

Device Description : HELIOS Ⅲ Arm

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HELIOS Ⅲ Zoom Handpiece - 08800035500023 Catalog Number :

Device Description : HELIOS Ⅲ Zoom Handpiece

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HELIOS Ⅲ 532 Fractional Handpiece - 08800035500030 Catalog Number :

Device Description : HELIOS Ⅲ 532 Fractional Handpiece

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HELIOS Ⅲ 1064 Fractional Handpiece - 08800035500047 Catalog Number :

Device Description : HELIOS Ⅲ 1064 Fractional Handpiece

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HELIOS Ⅲ Collimator Handpiece - 08800035500054 Catalog Number :

Device Description : HELIOS Ⅲ Collimator Handpiece

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HELIOS Ⅲ User Manual - 08800035500061 Catalog Number :

Device Description : HELIOS Ⅲ User Manual

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HELIOS Ⅲ Service Manual - 08800035500078 Catalog Number :

Device Description : HELIOS Ⅲ Service Manual

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HELIOS Ⅱ power cable - 08800035500085 Catalog Number :

Device Description : HELIOS Ⅱ power cable

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HELIOS Ⅲ Foot Switch - 08800035500108 Catalog Number :

Device Description : HELIOS Ⅲ Foot Switch

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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