OPTIMEDICA CATALYS PRECISION LASER SYSTEM
FDA 510(k) clearance K141079 · decided 2014-09-11
Clearance details
- K-number
- K141079
- Device name
- OPTIMEDICA CATALYS PRECISION LASER SYSTEM
- Applicant
- Optimedica Corporation
- Decision
- Substantially Equivalent
- Date received
- 2014-04-25
- Decision date
- 2014-09-11
- Days to decision
- 139 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-Catalys - U - US product; Catalys-1 - International product recall (Z-1683-2015) | Optimedica Corporation | 2015-05-28 |
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