RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
FDA 510(k) clearance K110080 · decided 2011-02-24
Clearance details
- K-number
- K110080
- Device name
- RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
- Applicant
- Biolitec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-01-11
- Decision date
- 2011-02-24
- Days to decision
- 44 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
- East Longmeadow, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CERALAS I LASER (P050021) | Biolitec, Inc. | 2005-12-20 |