• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name lasers for temporary increase of clear nail in patients with onychomycosis
510(k) Number K121508
Device Name LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N
Original Applicant
FOTONA D.D.
stegne 7,
ljubljana,  SI 1210
Original Contact stojan tost
Regulation Number878.4810
Classification Product Code
PDZ  
Subsequent Product Code
GEX  
Date Received05/21/2012
Decision Date 12/12/2012
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
-
-