Alcon Laboratories, Inc.

Address:5850 Oberlin Drive, # 340,SAN DIEGO,CA,92121,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

Unit, phacofragmentation (HQC) (4) Accessories, soft lens products (LPN) (2) Vitrectomy, instrument cutter (MLZ) (2) CAMERA, CINE, MICROSURGICAL, WITHOUT AUDIO (FWJ) (1) Excimer laser system (LZS) (1)

Premarket Exempt

No Yes

Clear

OPTI-FREE PUREMOIST - 00300653610022 Catalog Number :

Device Description : Opti-Free Pure Moist Multi-Purpose Disinfecting Solution Twin Pack 12 oz.

Device Class :

Duns Number: 008018525

Premarket Exempt : No

Product Code : LPN

Prescription Use : No

Device Count : 1

ALCON - 00300653610060 Catalog Number :

Device Description : OPTI-FREE® PUREMOIST® Multi-Purpose Disinfecting Solution with HydraGrade

Device Class : 2

Duns Number: 008018525

Premarket Exempt : No

Product Code : LPN

Prescription Use : No

Device Count : 1

CONSTELLATION® HYPERVIT® TOTAL PLUS® - 00380650000958 Catalog Number :

Device Description : 25+®Ga HYPERVIT® Bevel 20K CPM TOTAL PLUS® Combined Procedure Pak

Device Class : 2

Duns Number: 008018525

Premarket Exempt : No

Product Code : MLZ

Prescription Use : Yes

Device Count : 1

CONSTELLATION® HYPERVIT® TOTAL PLUS® - 00380650000965 Catalog Number :

Device Description : 27+®Ga HYPERVIT® Bevel 20K CPM TOTAL PLUS® Combined Procedure Pak

Device Class : 2

Duns Number: 008018525

Premarket Exempt : No

Product Code : MLZ

Prescription Use : Yes

Device Count : 1

WAVELIGHT REFRACTIVE SUITE - 00380650001108 Catalog Number :

Device Description : STAND ALONE PATIENT BED

Device Class : 3

Duns Number: 008018525

Premarket Exempt : No

Product Code : LZS

Prescription Use : Yes

Device Count : 1

Ngenuity - 00380650001139 Catalog Number :

Device Description : Microsurgical Camera

Device Class : 1

Duns Number: 008018525

Premarket Exempt : Yes

Product Code : FWJ

Prescription Use : Yes

Device Count : 1

Alcon - 00380650001276 Catalog Number :

Device Description : ACTIVE FMS, BASIC

Device Class : 2

Duns Number: 008018525

Premarket Exempt : No

Product Code : HQC

Prescription Use : Yes

Device Count : 1

Alcon - 00380650001283 Catalog Number :

Device Description : ACTIVE FMS W/ 0.9 MM INFUSION SLEEVES, 0.9 MM Tipless

Device Class : 2

Duns Number: 008018525

Premarket Exempt : No

Product Code : HQC

Prescription Use : Yes

Device Count : 1

Alcon - 00380650001290 Catalog Number :

Device Description : ACTIVE FMS W/ INTREPID* ULTRA SLEEVES, 0.9 MM Tipless

Device Class : 2

Duns Number: 008018525

Premarket Exempt : No

Product Code : HQC

Prescription Use : Yes

Device Count : 1

Alcon - 00380650001306 Catalog Number :

Device Description : ACTIVE FMS W/ INTREPID* NANO SLEEVES, 0.9 MM Tipless

Device Class : 2

Duns Number: 008018525

Premarket Exempt : No

Product Code : HQC

Prescription Use : Yes

Device Count : 1

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