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 Lens, Surgical, Laser, Accesssory, Ophthalmic Laser
510(k) Number K883270
Device Name IRIS ND:YAG OPTHALMIC LASER
Applicant
California Laboratories, Inc.
2270-M Camino Vida Roble
Carlsbad,  CA  92009 -4894
Applicant Contact KENNETH R MICHAEL
Correspondent
California Laboratories, Inc.
2270-M Camino Vida Roble
Carlsbad,  CA  92009 -4894
Correspondent Contact KENNETH R MICHAEL
Regulation Number886.4390
Classification Product Code
LQJ  
Date Received08/03/1988
Decision Date 10/13/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-