CERALAS D 980 DIODE LASER SYSTEM, MODELS D15, D25, D50
FDA 510(k) clearance K032863 · decided 2004-03-19
Clearance details
- K-number
- K032863
- Device name
- CERALAS D 980 DIODE LASER SYSTEM, MODELS D15, D25, D50
- Applicant
- Biolitec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-09-12
- Decision date
- 2004-03-19
- Days to decision
- 189 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
- Washington, DC, 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 |