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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K202953
Device Name Aurolase Therapy, Laser Delivery Device (LDD)
Applicant
Nanospectra Biosciences, Inc.
8285 El Rio St., #150
Houston,  TX  77054
Applicant Contact David Jorden
Correspondent
Bentley Biomedical Consulting, LLC
28241 Crown Valley Pkwy.
Suite 510(K)
Laguna Niguel,  CA  92677
Correspondent Contact Shepard G. Bentley
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/30/2020
Decision Date 10/03/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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