PMA P150034S005

Device: Raindrop Near Vision Inlay
Applicant: Rvo 2.0, Inc. (D.B.A. Optics Medical)
PMA number: P150034
Supplement: S005
Product code: LQE
Decision date: 2018-03-27
Classification: Implant, Corneal, Refractive
Generic name: Implant, corneal, refractive
Approval order statement: Approval to update the device labeling with the 36-month results for the Raindrop® Near Vision Inlay. In addition, the labeling includes minor changes (changing the temperature limit symbol maximum from 55°C to 25°C, removal of translations, updates to the Instructions for Use).

Current openFDA PMA Record#

Device: Raindrop Near Vision Inlay
Applicant: Rvo 2.0, Inc. (D.B.A. Optics Medical)
PMA number: P150034
Supplement: S005
Product code: LQE
Generic name: Implant, corneal, refractive
Decision date: 2018-03-27
Decision code: APPR
Date received: 2017-09-29
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to update the device labeling with the 36-month results for the Raindrop® Near Vision Inlay. In addition, the labeling includes minor changes (changing the temperature limit symbol maximum from 55°C to 25°C, removal of translations, updates to the Instructions for Use).