IRIDERM, MODEL APEX 800
FDA 510(k) clearance K992298 · decided 1999-12-09
Clearance details
- K-number
- K992298
- Device name
- IRIDERM, MODEL APEX 800
- Applicant
- Iridex Corp
- Decision
- Substantially Equivalent
- Date received
- 1999-07-08
- Decision date
- 1999-12-09
- Days to decision
- 154 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.