TOPCON MEDICAL LASER SYSTEMS, INC.

Address:111 Bauer Dr,Oakland,NJ,07436,US

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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

Laser, ophthalmic (HQF) (10) Powered laser surgical instrument (GEX) (10)

Premarket Exempt

No Yes

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PASCAL Synthesis - 00855005006003 Catalog Number : SA-06280

Device Description : (532) PASCAL, SYNTHESIS III CONSOLE (PACKED) A1 RELEASE

Device Class : 2

Duns Number: 041376321

Premarket Exempt : No

Product Code : GEX, HQF

Prescription Use : Yes

Device Count : 1

PASCAL Synthesis - 00855005006010 Catalog Number : SA-06281

Device Description : (577) PASCAL, SYNTHESIS III CONSOLE (PACKED) A1 RELEASE

Device Class : 2

Duns Number: 041376321

Premarket Exempt : No

Product Code : HQF, GEX

Prescription Use : Yes

Device Count : 1

PASCAL Synthesis - 00855005006027 Catalog Number : SA-06284

Device Description : (532) CONSOLE PA-03, SYNTHESIS III PACKED B RELEASE

Device Class : 2

Duns Number: 041376321

Premarket Exempt : No

Product Code : HQF, GEX

Prescription Use : Yes

Device Count : 1

PASCAL Synthesis - 00855005006034 Catalog Number : SA-06285

Device Description : (577) CONSOLE PA-03, SYNTHESIS III PACKED B RELEASE

Device Class : 2

Duns Number: 041376321

Premarket Exempt : No

Product Code : GEX, HQF

Prescription Use : Yes

Device Count : 1

PASCAL Synthesis - 00855005006041 Catalog Number : SA-06376

Device Description : Synthesis SLC & ESF (532nm) for BQ LED SN 293 or Higher & BQ Tungsten Bulb SN 17 Synthesis SLC & ESF (532nm) for BQ LED SN 293 or Higher & BQ Tungsten Bulb SN 17015 or Higher A

Device Class : 2

Duns Number: 041376321

Premarket Exempt : No

Product Code : GEX, HQF

Prescription Use : Yes

Device Count : 1

PASCAL Synthesis - 00855005006058 Catalog Number : SA-06377

Device Description : Synthesis SLC & ESF (577nm) for BQ LED SN 293 or Higher & BQ Tungsten Bulb SN 17 Synthesis SLC & ESF (577nm) for BQ LED SN 293 or Higher & BQ Tungsten Bulb SN 17015 or Higher B

Device Class : 2

Duns Number: 041376321

Premarket Exempt : No

Product Code : GEX, HQF

Prescription Use : Yes

Device Count : 1

PASCAL Synthesis - 00855005006065 Catalog Number : SA-06195

Device Description : PASCAL Synthesis SLC & ESF (532 nm) for BM C RELEASE

Device Class : 2

Duns Number: 041376321

Premarket Exempt : No

Product Code : GEX, HQF

Prescription Use : Yes

Device Count : 1

PASCAL Synthesis - 00855005006072 Catalog Number : SA-06197

Device Description : PASCAL Synthesis SLC & ESF (577 nm) for BM B1 RELEASE

Device Class : 2

Duns Number: 041376321

Premarket Exempt : No

Product Code : HQF, GEX

Prescription Use : Yes

Device Count : 1

PASCAL Synthesis - 00855005006089 Catalog Number : SA-06194

Device Description : PASCAL Synthesis SLC & ESF (532 nm) for BQ B1 RELEASE

Device Class : 2

Duns Number: 041376321

Premarket Exempt : No

Product Code : HQF, GEX

Prescription Use : Yes

Device Count : 1

PASCAL Synthesis - 00855005006096 Catalog Number : SA-06196

Device Description : PASCAL Synthesis SLC & ESF (577 nm) for BQ B1 RELEASE

Device Class : 2

Duns Number: 041376321

Premarket Exempt : No

Product Code : GEX, HQF

Prescription Use : Yes

Device Count : 1

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