FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33
K Number: K901638
·
Decision Jun 27, 1990
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
8
Review Days
79
Basic Information
- Device Name
- MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33
- K Number
- K901638
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- LASERMATIC, INC.
- Date Received
- April 9, 1990
- Decision Date
- June 27, 1990
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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Other Clearances by LASERMATIC, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K903131 | LASERMATIC SUPERCOMBO(TM) SURGICAL LASER SYSTEM | Feb 19, 1991 | Substantially Equivalent |
| K893529 | COMBOLASER MODEL 5050 | Jun 8, 1989 | Substantially Equivalent |
| K871875 | MODEL 5050 SURGILASER FOR OB-GYN USE | Aug 22, 1988 | Substantially Equivalent |
| K871932 | MODEL 5050 SURGILASER FOR UROLOGY USE | Mar 25, 1988 | Substantially Equivalent |
| K871934 | MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE | Mar 25, 1988 | Substantially Equivalent |
| K871933 | MODEL 5050 SURGILASER FOR NEUROSURGERY USE | Jan 22, 1988 | Substantially Equivalent |
| K871876 | MODEL 5050 SURGILASER FOR PULMONARY USE | Jan 22, 1988 | Substantially Equivalent |