FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGICAL CO2 LASER SYSTEM #20/OPTICAL FOR ARTHROSC
K Number: K854998
·
Decision May 2, 1986
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
39
Review Days
141
Basic Information
- Device Name
- SURGICAL CO2 LASER SYSTEM #20/OPTICAL FOR ARTHROSC
- K Number
- K854998
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- DIRECTED ENERGY, INC.
- Date Received
- December 12, 1985
- Decision Date
- May 2, 1986
- 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 DIRECTED ENERGY, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K904930 | SURGICAL CARBON DIOXIDE LASER SYST MODEL 20-CH | Mar 21, 1991 | Substantially Equivalent |
| K894241 | MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENT | Jun 18, 1990 | Substantially Equivalent |
| K883738 | CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH. | Nov 15, 1988 | Substantially Equivalent |
| K882926 | MODEL AU-1 ACCESSORY UNIT | Sep 9, 1988 | Substantially Equivalent |
| K880216 | MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP. | Mar 4, 1988 | Substantially Equivalent |
| K873331 | ORTHO. GAS INSUFFLATOR MODEL IN-2 FOR ARTHRO. SURG | Feb 17, 1988 | Substantially Equivalent |
| K872709 | MODEL 20-C, RL-20A/U, OB-10A/U | Feb 2, 1988 | Substantially Equivalent |
| K870841 | MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN | Feb 2, 1988 | Substantially Equivalent |
| K872711 | MODEL 20-C W/AR-10A/U ATTACH. FOR ARTHRO. SURGERY | Sep 28, 1987 | Substantially Equivalent |
| K872710 | MODEL 20-B W/OB-10A/U ATTACH. FOR EAR, NOSE/THROAT | Sep 24, 1987 | Substantially Equivalent |