SVS APEX APEX EXIMER LASER WORKSTATION
FDA premarket approval P930034/S003 · decided 1996-11-25
Approval details
- PMA number
- P930034
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Other
- Trade name
- SVS APEX APEX EXIMER LASER WORKSTATION
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 1996-03-12
- Decision date
- 1996-11-25
- Days to decision
- 258 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Orlando, FL
- Statement
- ALL LABELING MUST CONTAIN THE FOLLOWING PRECAUTION STATEMENT: PRECAUTION: ALTHOUGH THE EFFECTS OF PRK ON VISUAL PERFORMANCE UNDER POOR LIGHTING CONDITIONS HAVE NOT BEEN DETERMINED, IT IS POSSIBLE THAT YOU WILL FIND IT MORE DIFFICULT THAN USUAL TO SEE IN CONDITIONS SUCH AS VERY DIM LIGHT, RAIN, SNOW, FOG, OR GLARE FROM BRIGHT LIGHTS AT NIGHT.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal (K254052) | Alcon Laboratories, Inc. | 2026-02-13 |
| LenSx Laser System (8065000944) (K252682) | Alcon Laboratories, Inc. | 2025-09-24 |
| LenSx Laser System (8065998162) (K243896) | Alcon Laboratories, Inc. | 2025-04-28 |
| Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric (K243909) | Alcon Laboratories, Inc. | 2025-01-13 |
| Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); (K242184) | Alcon Laboratories, Inc. | 2024-12-04 |
| UNITY VCS (8065000296); UNITY CS (8065000297) (K233876) | Alcon Laboratories, Inc. | 2024-06-21 |
| Centurion™ Vision System (Active Sentry™) (8065753057) (K233902) | Alcon Laboratories, Inc. | 2024-01-10 |
| Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30 Multifocal (K233856) | Alcon Laboratories, Inc. | 2023-12-29 |