FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DERMATHERM 100
K Number: K980607
·
Decision Apr 3, 1998
Classifications
1
FEI Numbers
462
Registration Numbers
462
Same Product Code
228
Applicant Total
29
Review Days
45
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Basic Information
- Device Name
- DERMATHERM 100
- K Number
- K980607
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- New Star Lasers, Inc.
- Date Received
- February 17, 1998
- Decision Date
- April 3, 1998
- Product Code
- ILY
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
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Other Clearances by New Star Lasers, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K142286 | NS3000 Holmium Laser System | Oct 31, 2014 | Substantially Equivalent |
| K132607 | NS 2500 HOLMIUM LASER SYSTEM | Mar 21, 2014 | Substantially Equivalent |
| K103338 | COOLTOUCH | Nov 1, 2011 | Substantially Equivalent |
| 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 |