FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SHARPLAN 1041 SEALED-OFF CO2 SURGICAL LASER SYSTEM
K Number: K900077
·
Decision Mar 6, 1990
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
78
Review Days
61
Basic Information
- Device Name
- SHARPLAN 1041 SEALED-OFF CO2 SURGICAL LASER SYSTEM
- K Number
- K900077
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- SHARPLAN LASERS, INC.
- Date Received
- January 4, 1990
- Decision Date
- March 6, 1990
- 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 SHARPLAN LASERS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K973354 | SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) | Dec 4, 1997 | Substantially Equivalent |
| K972099 | SHARPLAN EPITOUCH RUBY LASER SYSTEM | Aug 27, 1997 | Substantially Equivalent |
| K971874 | SHARPLAN EPITOUCH ALEXANDRITE LASER SYSTEM (5000) | Aug 18, 1997 | Substantially Equivalent |
| K971648 | SHARPLAN ERBIUM: YAG LASER (4020) | Jul 23, 1997 | Substantially Equivalent |
| K971743 | SHARPLAN CO2 SURGICAL LASER SYSTEM | Jul 18, 1997 | Substantially Equivalent |
| K962446 | SHARPLAN RUBY LASER SYSTEM | Mar 7, 1997 | Substantially Equivalent |
| K963229 | SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS | Nov 5, 1996 | Substantially Equivalent |
| K961935 | SHARPLAN LASERS, INC. SILKTOUCH CO2 FLASH SCANNER | Nov 1, 1996 | Substantially Equivalent |
| K962974 | SHARPLAN LASERS, INC. AF ACUSPOT MICROMANIPULATOR (713) | Aug 21, 1996 | Substantially Equivalent |
| K961279 | SHARPLAN LASERS, INC. RUBY LASER SYSTEM | Jun 18, 1996 | Substantially Equivalent |