Premarket Approval (PMA)

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.

• Device: Raindrop Near Vision Inlay
• Generic Name: Implant, corneal, refractive
• Applicant: Rvo 2.0, Inc. (D.B.A. Optics Medical); 65 Enterprise, Suite 455; Aliso Viejo, CA 92656
• PMA Number: P150034
• Supplement Number: S006
• Date Received: 12/18/2017
• Decision Date: 01/12/2018
• Product Code: LQE
• Advisory Committee: Ophthalmic
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Alternative shortened purification process for the Raindrop® Near Vision Inlay.