OCULIGHT GL/GLX
FDA 510(k) clearance K050562 · decided 2005-04-14
Clearance details
- K-number
- K050562
- Device name
- OCULIGHT GL/GLX
- Applicant
- Iridex Corp
- Decision
- Substantially Equivalent
- Date received
- 2005-03-03
- Decision date
- 2005-04-14
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mountain View, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.