FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MD CO2 SURGICAL LASER SYSTEM/GEN. SURGERY AND ORTH
K Number: K905676
·
Decision Apr 22, 1991
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
18
Review Days
125
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Basic Information
- Device Name
- MD CO2 SURGICAL LASER SYSTEM/GEN. SURGERY AND ORTH
- K Number
- K905676
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Laser Engineering, Inc.
- Date Received
- December 18, 1990
- Decision Date
- April 22, 1991
- 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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| K911852 | COMPULSE CO2 SURGICAL LASER SYS. | Jun 7, 1991 | Substantially Equivalent |
| K875314 | GL-35 COLPOSCOPIC LASER SYSTEM | Aug 5, 1988 | Substantially Equivalent |
| K881587 | MODEL MD-25 CO2 LASER FOR PODIATRY APPLICATIONS | Jun 3, 1988 | Substantially Equivalent |
| K881580 | MODEL MD-25 CO2 LASER FOR DERMA./PLASTIC SURGERY | Jun 3, 1988 | Substantially Equivalent |