FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II
K Number: K022817
·
Decision Nov 22, 2002
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
30
Review Days
88
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Basic Information
- Device Name
- COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II
- K Number
- K022817
- 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
- Icn Pharmaceuticals, Inc.
- Date Received
- August 26, 2002
- Decision Date
- November 22, 2002
- 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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|---|---|---|---|
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| K914086 | ICAN CYLINDRICAL SPONGES | Oct 9, 1991 | Substantially Equivalent |
| K914081 | ICAN COTTON RAYON BALLS | Oct 9, 1991 | Substantially Equivalent |
| K913446 | ICAN NEEDLE COUNTERS | Sep 13, 1991 | Substantially Equivalent |
| K904398 | WATER COLUMN RELIEF VALVE | Jul 9, 1991 | Substantially Equivalent |
| K770458 | BILIRUBIN PROCEDURE, TEKPOINT TOT & DIR. | May 10, 1977 | Substantially Equivalent |
| K770453 | PHOSPHATASE PROCEDURE, TEKPOINT ALKALINE | May 3, 1977 | Substantially Equivalent |