FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CELL ROBOTICS ER: YAG SURGICAL LASER
K Number: K970461
·
Decision Jul 11, 1997
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
9
Review Days
155
Basic Information
- Device Name
- CELL ROBOTICS ER: YAG SURGICAL LASER
- K Number
- K970461
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CELL ROBOTICS, INC.
- Date Received
- February 6, 1997
- Decision Date
- July 11, 1997
- 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 CELL ROBOTICS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K033799 | CLINICAL LASETTE P-200 | Dec 22, 2003 | Substantially Equivalent |
| K021946 | CELL ROBOTICS ULTRA-LIGHT PEEL LASER SYSTEM | Sep 11, 2002 | Substantially Equivalent |
| K983673 | LASETTE | Jan 15, 1999 | Substantially Equivalent |
| K981746 | CELL ROBOTICS' LASETTE | Dec 7, 1998 | Substantially Equivalent |
| K982230 | LASETTE LASER SKIN PERFORATOR | Sep 24, 1998 | Substantially Equivalent |
| K981149 | LASETTE LASER SKIN PERFORATOR | Jun 29, 1998 | Substantially Equivalent |
| K973431 | LASETTE | Oct 28, 1997 | Substantially Equivalent |
| K965124 | LASETTE | Aug 14, 1997 | Substantially Equivalent |