NaturaLase CO2 Laser System
FDA 510(k) clearance K152529 · decided 2016-02-04
Clearance details
- K-number
- K152529
- Device name
- NaturaLase CO2 Laser System
- Applicant
- Focus Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-09-03
- Decision date
- 2016-02-04
- Days to decision
- 154 days
- Clearance type
- Abbreviated
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Bethel, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.