VISX EXCIMER LASER SYSTEM MODELS B AND C
FDA premarket approval P930016/S005 · decided 1998-01-29
Approval details
- PMA number
- P930016
- Supplement
- S005
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VISX EXCIMER LASER SYSTEM MODELS B AND C
- Generic name
- Excimer laser system
- Applicant
- Amo Manufacturing USA, LLC
- Date received
- 1997-07-23
- Decision date
- 1998-01-29
- Days to decision
- 190 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- Yes
- Location
- Milpitas, CA
- Statement
- Approval for the VISX Excimer Laser System (Models B and C). This device is indicated for myopic and astigmatic PRK using an ablation zone with a 6.0 mm major axis. The PRK procedure is intended for use: 1)in patients with documented evidence of a change in manifest refraction of less than or equal to 0.5D (in both cylinder and sphere components) per year for at least one year prior to the date of the pre-operative examination; and 2) in patients 18-20 years of age in PRK treatments for the redu
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510(k) clearances by this applicant
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|---|---|---|
| Catalys™ Precision Laser System (K223838) | Amo Manufacturing USA, LLC | 2023-04-12 |
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| CATALYS Precision Laser System (K210701) | Amo Manufacturing USA, LLC | 2021-04-07 |
| Catalys Precision Laser System (K182083) | Amo Manufacturing USA, LLC | 2018-11-09 |
| Catalys Precision Laser System (K172002) | Amo Manufacturing USA, LLC | 2017-08-25 |
| IFS ADVANCED FEMTOSECOND LASER SYSTEM (K141852) | Amo Manufacturing USA, LLC | 2015-01-06 |