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510(k) K101190

LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC by Led Intellectual Properties, LLC — Product Code OHS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2010
Date Received
April 28, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Based Over The Counter Wrinkle Reduction
Device Class
Class II
Regulation Number
878.4810
Review Panel
SU
Submission Type

Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.

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  • K131461 — LIGHTSTIM FOR ACNE/ LIGHTSTIM FOR ACNE MINI (January 6, 2014)
  • K120775 — LIGHT FOR WRINKLES (June 4, 2012)
  • K092800 — ANTI-WRINKLE (AGING) LIGHT, MODEL AAL (February 4, 2010)
  • K083580 — ANTI-WRINKLE LIGHT, MODEL 1302 AND PAIN THERAPY LIGHT, MODEL 1301 (June 22, 2009)

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