FDA 510(k), K140249, LONG PULSE ND: YAG LASER SYSTEM

FDA 510(k), K140249, LONG PULSE ND: YAG LASER SYSTEM

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510(K) Number: K140249
Device Name: LONG PULSE ND: YAG LASER SYSTEM
Manufacturer: ADVANCED TECHNOLOGY LASER CO., LTD.
Device Classification Name: powered laser surgical instrument
Regulation Number: 878.4810
Classification Product Code: GEX
Date Received: 01/31/2014
Decision Date: 10/08/2014
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. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.

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