FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
02-10,001
K Number: K910062
·
Decision Aug 16, 1991
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
17
Review Days
219
Basic Information
- Device Name
- 02-10,001
- K Number
- K910062
- 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
- January 9, 1991
- Decision Date
- August 16, 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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|---|---|---|---|
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| K875314 | GL-35 COLPOSCOPIC LASER SYSTEM | Aug 5, 1988 | Substantially Equivalent |
| K881582 | MODEL MD-45 CO2 LASER FOR DERMATOLOGY/PODIATRY USE | Jun 3, 1988 | Substantially Equivalent |
| K881584 | MODEL MD-45 CO2 LASER FOR NEUROSURGERY USE | Jun 3, 1988 | Substantially Equivalent |
| K881583 | MODEL MD-25 CO2 LASER FOR EAR, NOSE & THROAT | Jun 3, 1988 | Substantially Equivalent |