GENTLERAY 980 DIODE LASER SYSTEM
FDA 510(k) clearance K072262 · decided 2007-10-26
Clearance details
- K-number
- K072262
- Device name
- GENTLERAY 980 DIODE LASER SYSTEM
- Applicant
- Kavo America
- Decision
- Substantially Equivalent
- Date received
- 2007-08-15
- Decision date
- 2007-10-26
- Days to decision
- 72 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
- Lake Zurich, IL, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.