FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NUVE FOR WRINKLES, DPL NUVE FOR WRINKLES
K Number: K141181
·
Decision Mar 31, 2015
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
114
Applicant Total
3
Review Days
328
Basic Information
- Device Name
- NUVE FOR WRINKLES, DPL NUVE FOR WRINKLES
- K Number
- K141181
- 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
- LED TECHNOLOGIES, LLC
- Date Received
- May 7, 2014
- Decision Date
- March 31, 2015
- Product Code
- OHS
- 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 |
|---|---|---|---|
| OHS | Light Based Over The Counter Wrinkle Reduction | FDA class 2 | General, Plastic Surgery |
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