FIBER ONE
FDA 510(k) clearance K100746 · decided 2010-06-11
Clearance details
- K-number
- K100746
- Device name
- FIBER ONE
- Applicant
- American Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2010-03-16
- Decision date
- 2010-06-11
- Days to decision
- 87 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
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GreenLight MoXy Fiber Optic, part number 0010-2400, for use with the GreenLight XPS Laser recall (Z-0834-2011) | AMS Innovative Center - San Jose | 2010-12-29 |