BAUSCH & LOMB KERACOR 116 EXCIMER LASER SYSTEM
FDA premarket approval P970056 · decided 1999-09-28
Approval details
- PMA number
- P970056
- Trade name
- BAUSCH & LOMB KERACOR 116 EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Technolas GmbH Perfect Vision
- Date received
- 1997-11-13
- Decision date
- 1999-09-28
- Days to decision
- 684 days
- Decision code
- APWD
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Anaheim Hills, CA
- Statement
- Approval for 16 units of the KERACOR(R) 116 ophthalmic excimer laser system. This device is indicated for myopic photorefractive keratectomy (PRK) in patients who meet the following criteria: 1) In Photorefractive Keratectomy (PRK) treatments for the reduction or elimination of myopia between -1.50 to -7.00D of sphere and less than or equal to -4.5D of astigmatism. 2) In patients with documented evidence of a change in manifest refraction of less than or equal to 0.50 diopters (in both cylinder
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