ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE
FDA 510(k) clearance K112166 · decided 2011-10-21
Clearance details
- K-number
- K112166
- Device name
- ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE
- Applicant
- W and R Investments Dba Laser Engineering
- Decision
- Substantially Equivalent
- Date received
- 2011-07-28
- Decision date
- 2011-10-21
- Days to decision
- 85 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
- Milford, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.