CANDELA GENTLELASE GL DERMATOLOGICAL VASCULAR LESION LASER
FDA 510(k) clearance K972767 · decided 1997-12-04
Clearance details
- K-number
- K972767
- Device name
- CANDELA GENTLELASE GL DERMATOLOGICAL VASCULAR LESION LASER
- Applicant
- Candela Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-07-24
- Decision date
- 1997-12-04
- Days to decision
- 133 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
- Wayland, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - M recall (Z-0348-2014) | Candela Corporation | 2013-11-18 |