Laseroptek Co.,Ltd

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

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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

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HELIOS Ⅲ Power Cable - 08800035500115 Catalog Number :

Device Description : HELIOS Ⅲ Power Cable

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HELIOS Ⅱ body - 08800035500122 Catalog Number :

Device Description : HELIOS Ⅱ body

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HELIOS Ⅱ Arm - 08800035500139 Catalog Number :

Device Description : HELIOS Ⅱ Arm

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HELIOS Ⅱ Zoom Handpiece - 08800035500146 Catalog Number :

Device Description : HELIOS Ⅱ Zoom Handpiece

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HELIOS Ⅱ 532 Fractional Handpiece - 08800035500153 Catalog Number :

Device Description : HELIOS Ⅱ 532 Fractional Handpiece

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HELIOS Ⅱ 1064 Fractional Handpiece - 08800035500160 Catalog Number :

Device Description : HELIOS Ⅱ 1064 Fractional Handpiece

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HELIOS Ⅱ Collimator Handpiece - 08800035500177 Catalog Number :

Device Description : HELIOS Ⅱ Collimator Handpiece

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HELIOS Ⅱ User Manual - 08800035500184 Catalog Number :

Device Description : HELIOS Ⅱ User Manual

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HELIOS Ⅱ Service Manual - 08800035500191 Catalog Number :

Device Description : HELIOS Ⅱ Service Manual

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HELIOS Ⅱ Foot Switch - 08800035500207 Catalog Number :

Device Description : HELIOS Ⅱ Foot Switch

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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