CATALYS PRECISION LASER SYSTEM
FDA 510(k) clearance K121091 · decided 2012-08-28
Clearance details
- K-number
- K121091
- Device name
- CATALYS PRECISION LASER SYSTEM
- Applicant
- Optimedica Corporation
- Decision
- Substantially Equivalent
- Date received
- 2012-04-10
- Decision date
- 2012-08-28
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- OOE
- Device class
- 2
- Regulation number
- 886.4390
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser System recall (Z-0649-2014) | Optimedica Corporation | 2014-01-08 |