MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33
FDA 510(k) clearance K901638 · decided 1990-06-27
Clearance details
- K-number
- K901638
- Device name
- MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33
- Applicant
- Lasermatic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-04-09
- Decision date
- 1990-06-27
- Days to decision
- 79 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
- Attleboro, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.