CANDELA SPTL-1 LASER FOR TREATING BENIGN VASC. LES
FDA 510(k) clearance K900858 · decided 1990-10-03
Clearance details
- K-number
- K900858
- Device name
- CANDELA SPTL-1 LASER FOR TREATING BENIGN VASC. LES
- Applicant
- Candela Laser Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-02-23
- Decision date
- 1990-10-03
- Days to decision
- 222 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
No recalls on record reference this clearance.