SLIM E30 II CO2 LASER
FDA 510(k) clearance K110984 · decided 2011-07-22
Clearance details
- K-number
- K110984
- Device name
- SLIM E30 II CO2 LASER
- Applicant
- Lasering S.R.L.
- Decision
- Substantially Equivalent
- Date received
- 2011-04-07
- Decision date
- 2011-07-22
- Days to decision
- 106 days
- Clearance type
- Special
- Product code
- ONG
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Ramon, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.