FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NUTRA LIGHT RED
K Number: K141308
·
Decision Aug 20, 2014
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
152
Applicant Total
9
Review Days
93
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Basic Information
- Device Name
- NUTRA LIGHT RED
- K Number
- K141308
- 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
- Nutra Luxe MD, LLC
- Date Received
- May 19, 2014
- Decision Date
- August 20, 2014
- 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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Other Clearances by Nutra Luxe MD, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K162371 | Pulsaderm ACE-All Blue | Dec 15, 2016 | Substantially Equivalent |
| K161941 | Pulsaderm Acne Device | Oct 19, 2016 | Substantially Equivalent |
| K160728 | NutraStim Hair Laser Helmet | Sep 16, 2016 | Substantially Equivalent |
| K150826 | Nutra Face Lift Model PE8050 | Feb 10, 2016 | Substantially Equivalent |
| K150370 | Nutra Light Advanced | Jul 22, 2015 | Substantially Equivalent |
| K141596 | NUTRA STIM HAIR LASER COMB | Jan 8, 2015 | Substantially Equivalent |
| K141588 | NUTRA STIM HAIR LASER COMB | Jan 8, 2015 | Substantially Equivalent |
| K132838 | NUTRA LIGHT BLUE | May 23, 2014 | Substantially Equivalent |