DENLASER 800 PLUS
FDA 510(k) clearance K061366 · decided 2006-07-10
Clearance details
- K-number
- K061366
- Device name
- DENLASER 800 PLUS
- Applicant
- CAO Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-05-16
- Decision date
- 2006-07-10
- Days to decision
- 55 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
- Sandy, UT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.