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

Premarket Approval (PMA)
  • 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
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceRaindrop Near Vision Inlay
Generic NameImplant, corneal, refractive
ApplicantRVO 2.0, Inc. (d.b.a. Optics Medical)
65 Enterprise Suite 455
Aliso Viejo, CA 92656
PMA NumberP150034
Supplement NumberS003
Date Received02/03/2017
Decision Date04/05/2017
Product Code LQE 
Advisory Committee Ophthalmic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for revisions to the Postoperative Care Following Inlay Implantation section of Instructions for Use (IFU) and Surgical Planning and Procedures” of the Professional Use Information Brochure for the Raindrop Near Vision Inlay.
-
-