FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
6 WATT HOLMIUM LASER SYSTEM
K Number: K952489
·
Decision Jan 22, 1996
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
28
Review Days
237
Basic Information
- Device Name
- 6 WATT HOLMIUM LASER SYSTEM
- K Number
- K952489
- 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
- NEW STAR LASERS, INC.
- Date Received
- May 30, 1995
- Decision Date
- January 22, 1996
- 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 NEW STAR LASERS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K132607 | NS 2500 HOLMIUM LASER SYSTEM | Mar 21, 2014 | Substantially Equivalent |
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| K101783 | COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZE | Sep 13, 2010 | Substantially Equivalent |
| K092964 | COOLTOUCH VARIA ND:YAG LASER SYSTEM | Dec 11, 2009 | Substantially Equivalent |
| K090410 | COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORY | Mar 27, 2009 | Substantially Equivalent |
| K081628 | MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPO | Jun 20, 2008 | Substantially Equivalent |
| K080163 | COOLTOUCH MODELS LC215 AND COOLLIPO | Apr 10, 2008 | Substantially Equivalent |
| K072751 | COOLTOUCH MODELS NS 160 AND LC215 COOLIPO | Jan 2, 2008 | Substantially Equivalent |
| K072424 | COOLTOUCH, MODEL LC215,COOLLIPO | Oct 3, 2007 | Substantially Equivalent |
| K062210 | COOL TOUCH, MODELS CT3S, CTEV, NS160, CTEV, LC160 | Sep 25, 2006 | Substantially Equivalent |