FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LITE TOUCH ERBIUM LASER TREATMENT SYSTEM
K Number: K974460
·
Decision Jan 16, 1998
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
12
Review Days
52
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Basic Information
- Device Name
- LITE TOUCH ERBIUM LASER TREATMENT SYSTEM
- K Number
- K974460
- 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
- Lorad Corp.
- Date Received
- November 25, 1997
- Decision Date
- January 16, 1998
- 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 Lorad Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K992280 | LORAD 1-650 (INTERNATIONAL 650) | Sep 3, 1999 | Substantially Equivalent |
| K973631 | LORAD M-III ELITE (M-III E) | Dec 23, 1997 | Substantially Equivalent |
| K952210 | LORAD STEROLOC II | Jul 24, 1995 | Substantially Equivalent |
| K945241 | LORAD M-IV, LORAD M-IVI | Mar 31, 1995 | Substantially Equivalent |
| K950608 | DIGITAL SPOT MAMMOGRAPHY FOR STEROTACTIC APPLICATION | Mar 2, 1995 | Substantially Equivalent |
| K945496 | MAMMOGRAPHIC X-RAY UNIT | Dec 27, 1994 | Substantially Equivalent |
| K945272 | RHODIUM FILTER | Dec 14, 1994 | Substantially Equivalent |
| K934868 | LORAD TRANSPO | Oct 14, 1994 | Substantially Equivalent |
| K934870 | LORAD D-550 | Jan 31, 1994 | Substantially Equivalent |
| K934748 | LORAD M-IIE MODIFICATION | Jan 31, 1994 | Substantially Equivalent |