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 K082721
Device Name LASERPRO 810, 940 AND 980 DIODE LASER SYSTEMS
Applicant
Photo Medex, Inc.
147 Keystone Dr.
Montgomeryville,  PA  18936
Applicant Contact ALFRED INTINTOLI
Correspondent
Photo Medex, Inc.
147 Keystone Dr.
Montgomeryville,  PA  18936
Correspondent Contact ALFRED INTINTOLI
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/17/2008
Decision Date 10/28/2008
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
Recalls CDRH Recalls
-
-