FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHARPLAN 720 CO2 SURGICAL LASER
K Number: K820101
·
Decision Feb 24, 1982
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
20
Review Days
40
Basic Information
- Device Name
- SHARPLAN 720 CO2 SURGICAL LASER
- K Number
- K820101
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- LASER INDUSTRIES LTD.
- Date Received
- January 15, 1982
- Decision Date
- February 24, 1982
- 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 LASER INDUSTRIES LTD.
| K Number | Device Name | ||
|---|---|---|---|
| K933362 | SHARPLAN CO2 SURGICAL LASER | Apr 7, 1994 | Substantially Equivalent |
| K894765 | SHARPLAN SMOKE EVACUATION UNIT, MODEL 100 | Sep 28, 1989 | Substantially Equivalent |
| K850628 | SHARPLAN 1040 CO/2 SURGICAL LASER | Aug 7, 1985 | Substantially Equivalent |
| K850633 | SHARPLAN MODEL 1060 CO/2 SURGICAL LASER | Aug 7, 1985 | Substantially Equivalent |
| K842997 | LASER RECTOSCOPE SET 784 | Aug 27, 1984 | Substantially Equivalent |
| K832550 | SHARPLAN #734 LASER SURGICAL UNIT | Apr 25, 1984 | Substantially Equivalent |
| K832551 | SHARPLAN #745 LASER SURG. UNIT | Apr 23, 1984 | Substantially Equivalent |
| K832316 | OPHTHALMIC ARGON LASER #700A | Jan 30, 1984 | Substantially Equivalent |
| K837573 | SHARPLAN LASER POSITIONING SYSTEM | Jun 28, 1983 | Substantially Equivalent |
| K837342 | SHARPLAN 721 CO2 SURGICAL LASER | May 18, 1983 | Substantially Equivalent |