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 Laser, Ophthalmic
510(k) Number K021538
Device Name LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR
Applicant
Lightmed Corp.
#1-1, Lane1,Pao-An St. Sec.3
Shulin City,  TW 238
Applicant Contact IRENE LIN
Correspondent
Lightmed Corp.
#1-1, Lane1,Pao-An St. Sec.3
Shulin City,  TW 238
Correspondent Contact IRENE LIN
Regulation Number886.4390
Classification Product Code
HQF  
Subsequent Product Code
GEX  
Date Received05/10/2002
Decision Date 08/08/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-