PROVISC Ophthalmic Viscosurgical Device
FDA premarket approval P890047/S070 · decided 2026-08-04
Approval details
- PMA number
- P890047
- Supplement
- S070
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PROVISC Ophthalmic Viscosurgical Device
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Alcon Research, Ltd.
- Date received
- 2026-02-27
- Decision date
- 2026-08-04
- Days to decision
- 158 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- An alternate manufacturing site at Alcon Fort Worth Manufacturing located at 6201 South Freeway, Fort Worth, Texas to perform the semiautomatic assembly of filled OVD (PROVISC, VISCOAT, and DUOVISC) syringes and components into blister packs, and packaging.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CENTURION Vision System (Active SentryTM) (K161794) | Alcon Research, Ltd. | 2017-04-14 |
| HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ (K170520) | Alcon Research, Ltd. | 2017-03-22 |
| CONSTELLATION VISION SYSTEM (K141065) | Alcon Research, Ltd. | 2014-08-22 |
| WAVELIGHT FS200 PATIENT INTERFACE 1505 (K121031) | Alcon Research, Ltd. | 2012-06-21 |
| MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4) (K112977) | Alcon Research, Ltd. | 2012-03-27 |
| 27+ ULTRAVIT PROBE, 27+ FLEX-TIP LASER PROBE, 27+ ENDOILLUMINATOR PROBE, 27+ VALVED ENTRY SYSTEM, 27+ INFUSION CANNULA (K110951) | Alcon Research, Ltd. | 2011-10-17 |
| CLEARCUT S SAFETY KNIFE (K110166) | Alcon Research, Ltd. | 2011-05-20 |
| ALCON MULTI-PIRPOSE DISINFECTING SOLUTION (K102860) | Alcon Research, Ltd. | 2011-05-10 |