FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIGHTSTIM FOR ACNE/ LIGHTSTIM FOR ACNE MINI
K Number: K131461
·
Decision Jan 6, 2014
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
48
Applicant Total
9
Review Days
231
Basic Information
- Device Name
- LIGHTSTIM FOR ACNE/ LIGHTSTIM FOR ACNE MINI
- K Number
- K131461
- 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 INTELLECTUAL PROPERTIES, LLC
- Date Received
- May 20, 2013
- Decision Date
- January 6, 2014
- Product Code
- OLP
- 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 |
|---|---|---|---|
| OLP | Over-The-Counter Powered Light Based Laser For Acne | FDA class 2 | General, Plastic Surgery |
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Other Clearances by LED INTELLECTUAL PROPERTIES, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K151336 | LightStim Professional 2-Panel Light | Oct 23, 2015 | Substantially Equivalent |
| K151333 | LightStim for Pain LED Belt | Aug 21, 2015 | Substantially Equivalent |
| K150098 | LightStim Professional 2-Panel Light | Apr 9, 2015 | Substantially Equivalent |
| K142246 | LightStim for Acne/ LightStim for Acne Mini | Jan 29, 2015 | Substantially Equivalent |
| K120775 | LIGHT FOR WRINKLES | Jun 4, 2012 | Substantially Equivalent |
| K101190 | LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC | Jul 1, 2010 | Substantially Equivalent |
| K092800 | ANTI-WRINKLE (AGING) LIGHT, MODEL AAL | Feb 4, 2010 | Substantially Equivalent |
| K083580 | ANTI-WRINKLE LIGHT, MODEL 1302 AND PAIN THERAPY LIGHT, MODEL 1301 | Jun 22, 2009 | Substantially Equivalent |