FDA 510(k), K132833, ULTRA RENEW PLUS

FDA 510(k), K132833, ULTRA RENEW PLUS

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510(K) Number: K132833
Device Name: ULTRA RENEW PLUS
Manufacturer: ACCORD MEDIA
Device Classification Name: over-the-counter powered light based laser for acne
Regulation Number: 878.4810
Classification Product Code: OLP
Date Received: 09/10/2013
Decision Date: 06/17/2014
Regulation Medical Specialty: General & Plastic Surgery
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.

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