Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Powered Laser Surgical Instrument
510(k) Number K884431
Device Name HEXASCAN HANDPIECE FOR ARGON/DYE LASER
Applicant
California Laboratories, Inc.
5964 La Pl. Ct.
Carlsbad,  CA  92008
Applicant Contact KENNETH R MICHAEL
Correspondent
California Laboratories, Inc.
5964 La Pl. Ct.
Carlsbad,  CA  92008
Correspondent Contact KENNETH R MICHAEL
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/21/1988
Decision Date 12/02/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-