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 Ophthalmic Femtosecond Laser
510(k) Number K182083
Device Name Catalys Precision Laser System
Applicant
Amo Manufacturing USA, LLC
510 Cottonwood Dr.
Milpitas,  CA  95035
Applicant Contact James Patrick Garvey II
Correspondent
Amo Manufacturing USA, LLC
510 Cottonwood Dr.
Milpitas,  CA  95035
Correspondent Contact James Patrick Garvey II
Regulation Number886.4390
Classification Product Code
OOE  
Date Received08/02/2018
Decision Date 11/09/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-