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 K853890
Device Name OPHTHALMIC LASER PHOTOCOAGULATOR
Applicant
MIRA, INC.
87 RUMFORD AVE.
WALTHAM,  MA  02453 -3846
Applicant Contact MARK W FURLONG
Correspondent
MIRA, INC.
87 RUMFORD AVE.
WALTHAM,  MA  02453 -3846
Correspondent Contact MARK W FURLONG
Regulation Number886.4390
Classification Product Code
HQF  
Date Received09/19/1985
Decision Date 11/12/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-