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

PALLAS power cable - 08800035500214 Catalog Number :

Device Description : PALLAS power cable

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

LOTUS Ⅱ power cable - 08800035500238 Catalog Number :

Device Description : LOTUS Ⅱ power cable

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

PALLAS body - 08800035500245 Catalog Number :

Device Description : PALLAS body

Device Class :

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

PALLAS Arm - 08800035500252 Catalog Number :

Device Description : PALLAS Arm

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

PALLAS Handpiece - 08800035500269 Catalog Number :

Device Description : PALLAS Handpiece

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

PALLAS User Manual - 08800035500276 Catalog Number :

Device Description : PALLAS User Manual

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

PALLAS Service Manual - 08800035500283 Catalog Number :

Device Description : PALLAS Service Manual

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

PALLAS Foot Switch - 08800035500290 Catalog Number :

Device Description : PALLAS Foot Switch

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

HYPERION power cable - 08800035500306 Catalog Number :

Device Description : HYPERION power cable

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

LOTUS Ⅱ body - 08800035500320 Catalog Number :

Device Description : LOTUS Ⅱ body

Device Class : 2

Duns Number: 689856875

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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