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) (8)

Premarket Exempt

Clear

HELIOS IV 785 DIA FX 785 Handpiece - 08800035501488 Catalog Number :

Device Description : HELIOS IV 785 DIA FX 785 Handpiece

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HELIOS IV 785 785 Zoom Handpiece - 08800035501495 Catalog Number :

Device Description : HELIOS IV 785 785 Zoom Handpiece

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HELIOS IV 785 DIA FX 785 s Handpiece - 08800035501501 Catalog Number :

Device Description : HELIOS IV 785 DIA FX 785 s Handpiece

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HELIOS IV 785 785 CollimatorHandpiece - 08800035501518 Catalog Number :

Device Description : HELIOS IV 785 785 CollimatorHandpiece

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HELIOS IV 785 Foot Switch - 08800035501525 Catalog Number :

Device Description : HELIOS IV 785 Foot Switch

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HELIOS IV 785 User Manual - 08800035501532 Catalog Number :

Device Description : HELIOS IV 785 User Manual

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HELIOS IV 785 Body - 08800035501563 Catalog Number :

Device Description : HELIOS IV 785 Body

Device Class :

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HELIOS IV 785 Arm - 08800035501570 Catalog Number :

Device Description : HELIOS IV 785 Arm

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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