KREMER LASER SYSTEM
FDA premarket approval P970005 · decided 1998-07-30
Approval details
- PMA number
- P970005
- Trade name
- KREMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Lasersight Technologies, Inc.
- Date received
- 1997-01-31
- Decision date
- 1998-07-30
- Days to decision
- 545 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Winter Park, FL
- Statement
- Approval for a single laser, Kremer Excimer Laser System Serial No. KEA940202. This device, using a 6.0 mm ablation zone, is indicated for myopic and astigmatic laser in situ keratomileusis (LASIK) in patients: 1)with myopia ranging between -1.0 and -15.0 diopters (D) with or without astigmatism ranging from 0.0 D to 5.00 D; 2) who are 18 years of age or older; and 3) with stable refraction over the 1-year period prior to surgery. Note: Patients between 18 and 20 years old should not demonstrate
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS (K001144) | Lasersight Technologies, Inc. | 2000-05-05 |
| ULTRASHAPER KERATOME (K990227) | Lasersight Technologies, Inc. | 2000-01-31 |
| AUTOMATED DISPOSABLE KERATOME (ADK) (K974004) | Lasersight Technologies, Inc. | 1998-01-08 |