FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MINUTEMAN CO2 MICROSURG LASER DERMATOL-
K Number: K843517
·
Decision Dec 7, 1984
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
40
Applicant Total
5
Review Days
93
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MINUTEMAN CO2 MICROSURG LASER DERMATOL-
- K Number
- K843517
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4820
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- American Surgical Laser, Inc.
- Date Received
- September 5, 1984
- Decision Date
- December 7, 1984
- Product Code
- GEY
- 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 |
|---|---|---|---|
| GEY | Motor, Surgical Instrument, Ac-Powered | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEY), ordered by most recent decision date.
ADVANCED TURBO DRIVE SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SYMPHONY GRAFT DELIVERY SYSTEM (GDS)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MEDNEXT 1000 DRILL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
AQUA SPRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BONE AND MARROW COLLECTION SYSTEM KIT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by American Surgical Laser, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K843515 | MINUTEMAN CO2 MICROSURGICAL LASER GYN | Feb 4, 1985 | Substantially Equivalent |
| K843519 | MINUTEMAN CO2 MICROSURG LASER GEN SURG | Dec 7, 1984 | Substantially Equivalent |
| K843518 | MINUTEMAN C02 MICROSURG LASER PODIATRY | Dec 7, 1984 | Substantially Equivalent |
| K843514 | MINUTEMAN CO2 MICROSURGICAL LASER OTO | Dec 4, 1984 | Substantially Equivalent |