FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CO 2 SURGICAL LASER SYSTEM MODEL NA-40
K Number: K850805
·
Decision Aug 15, 1985
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
12
Review Days
169
Basic Information
- Device Name
- CO 2 SURGICAL LASER SYSTEM MODEL NA-40
- K Number
- K850805
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- XANAR, INC.
- Date Received
- February 27, 1985
- Decision Date
- August 15, 1985
- 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 XANAR, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K861688 | XANAR CO2 SURGICAL LASER SYSTEM MODEL XAP-15 | Oct 3, 1986 | Substantially Equivalent |
| K852436 | AMBULASE | Apr 18, 1986 | Substantially Equivalent |
| K860496 | MODEL NY-110 FOR UPPER & LOWER (GU) & PULMONARY | Mar 14, 1986 | Substantially Equivalent |
| K853620 | MODEL XA-50 - CO2 SURGICAL LASER | Jan 24, 1986 | Substantially Equivalent |
| K850804 | CO 2 SURGICAL LASER SYSTEM NA-30 | Aug 15, 1985 | Substantially Equivalent |
| K850818 | CO 2 SURGICAL LASER SYSTEM NA-120 | Aug 15, 1985 | Substantially Equivalent |
| K844087 | XANAR MODEL XSE-300 SMOKE EVACULATER | Feb 27, 1985 | Substantially Equivalent |
| K841860 | CO2 SURGICAL LASER SYSTEM XML-10 | Nov 8, 1984 | Substantially Equivalent |
| K833325 | AMBULASE XAM-15 XANAR SURG. LASER | Jan 26, 1984 | Substantially Equivalent |
| K837224 | UNKNOWN | May 2, 1983 | Substantially Equivalent |