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, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
510(k) Number K881459
Device Name NANOLAS ND:YAG OPHTHALMIC LASER
Applicant
Biophysic Medical, Inc.
2440 Estand Way
Pleasant Hill,  CA  94523
Applicant Contact DOUGLAS DONALDSON
Correspondent
Biophysic Medical, Inc.
2440 Estand Way
Pleasant Hill,  CA  94523
Correspondent Contact DOUGLAS DONALDSON
Classification Product Code
LOI  
Date Received04/06/1988
Decision Date 04/13/1988
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-