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 K022923
Device Name CANDELA GENTLE YAG LASER SYSTEM
Applicant
CANDELA CORP.
530 BOSTON POST RD.
WAYLAND,  MA  01778
Applicant Contact LORRAINE NELSON
Correspondent
CANDELA CORP.
530 BOSTON POST RD.
WAYLAND,  MA  01778
Correspondent Contact LORRAINE NELSON
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/04/2002
Decision Date 03/13/2003
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
-
-