LASERSCAN LSX EXCIMER LASER SYSTEM
FDA premarket approval P980008/S009 · decided 2001-11-09
Approval details
- PMA number
- P980008
- Supplement
- S009
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LASERSCAN LSX EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Lasersight Technologies, Inc.
- Date received
- 2001-10-26
- Decision date
- 2001-11-09
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Winter Park, FL
- Statement
- APPROVAL FOR A CHANGE TO THE QUALITY CONTROL PROCESS THAT WILL EXTEND THE BEAM REPEATABILITY TEST FROM 2 TO 8 HOURS TO MORE ACCURATELY RESEMBLE ACTUAL FIELD USE.
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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 |