CUTERA GENESISPLUS LASER SYSTEM
FDA 510(k) clearance K103626 · decided 2011-04-05
Clearance details
- K-number
- K103626
- Device name
- CUTERA GENESISPLUS LASER SYSTEM
- Applicant
- Cutera, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-12-10
- Decision date
- 2011-04-05
- Days to decision
- 116 days
- Clearance type
- Traditional
- Product code
- PDZ
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Brisbane, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.