LPULSA SYL-9000 OPHTHALMIC YAG LASER
FDA 510(k) clearance K990075 · decided 1999-03-30
Clearance details
- K-number
- K990075
- Device name
- LPULSA SYL-9000 OPHTHALMIC YAG LASER
- Applicant
- Light-Med(Usa), Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-01-11
- Decision date
- 1999-03-30
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- HQF
- Device class
- 2
- Regulation number
- 886.4390
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Laguna Hills, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Model LightLas 532 Opthalmic Photocoagulator Laser recall (Z-0228-04) | LightMed USA Inc | 2003-12-17 |