TOPCON MEDICAL LASER SYSTEMS, INC.

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

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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

Laser, ophthalmic (HQF) (7) Powered laser surgical instrument (GEX) (7) Projector, ophthalmic (HOS) (1)

Premarket Exempt

No Yes

Clear

PASCAL Synthesis - 00855005006201 Catalog Number : SA-06415

Device Description : PASCAL Synthesis, ASSY, SLC AND ESF, 577nm, SYNTHESIS III, TOPCON D7 aka SA-06175

Device Class : 2

Duns Number: 041376321

Premarket Exempt : No

Product Code : HQF, GEX

Prescription Use : Yes

Device Count : 1

Head-Up-Display, HUD-1 - 00855005006218 Catalog Number : SA-06427

Device Description : Head-Up-Display, HUD-1, Ophthalmic Projector

Device Class : 1

Duns Number: 041376321

Premarket Exempt : Yes

Product Code : HOS

Prescription Use : Yes

Device Count : 1

PASCAL Synthesis TwinStar - 00855005006232 Catalog Number : SA-06452

Device Description : PASCAL Synthesis TwinStar (577/638), PA-04 (PACKED)

Device Class : 2

Duns Number: 041376321

Premarket Exempt : No

Product Code : HQF, GEX

Prescription Use : Yes

Device Count : 1

PACSAL Synthesis - 00855005006249 Catalog Number : SA-06454

Device Description : PASCAL Synthesis (532), Green, PA-04 (PACKED)

Device Class : 2

Duns Number: 041376321

Premarket Exempt : No

Product Code : HQF, GEX

Prescription Use : Yes

Device Count : 1

PASCAL Synthesis - 00855005006256 Catalog Number : SA-06455

Device Description : PASCAL Synthesis (577), Yellow, PA-04 (PACKED)

Device Class : 2

Duns Number: 041376321

Premarket Exempt : No

Product Code : GEX, HQF

Prescription Use : Yes

Device Count : 1

PASCAL Synthesis TwinStar - 00855005006263 Catalog Number : SA-06453

Device Description : PASCAL Synthesis TwinStar (577/638), PA-04, JAPAN (PACKED)

Device Class : 2

Duns Number: 041376321

Premarket Exempt : No

Product Code : HQF, GEX

Prescription Use : Yes

Device Count : 1

PACSAL Synthesis - 00855005006270 Catalog Number : SA-06456

Device Description : PASCAL Synthesis (532), Green, PA-04, JAPAN (PACKED)

Device Class : 2

Duns Number: 041376321

Premarket Exempt : No

Product Code : GEX, HQF

Prescription Use : Yes

Device Count : 1

PACSAL Synthesis - 00855005006287 Catalog Number : SA-06457

Device Description : PASCAL Synthesis (577), Yellow, PA-04, JAPAN (PACKED)

Device Class : 2

Duns Number: 041376321

Premarket Exempt : No

Product Code : HQF, GEX

Prescription Use : Yes

Device Count : 1

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