Raindrop Near Vision Inlay

Implant, Corneal, Refractive

FDA Premarket Approval P150034 S005

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.

Pre-market Approval Supplement Details

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).

DeviceRaindrop Near Vision Inlay
Classification NameImplant, Corneal, Refractive
Generic NameImplant, Corneal, Refractive
ApplicantRVO 2.0, Inc. (d.b.a. Optics Medical)
Date Received2017-09-29
Decision Date2018-03-27
PMAP150034
SupplementS005
Product CodeLQE
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address RVO 2.0, Inc. (d.b.a. Optics Medical) 65 Enterprise Suite 455 aliso Viejo, CA 92656

Supplemental Filings

Supplement NumberDateSupplement Type
P150034Original Filing
S009 2021-12-09 Normal 180 Day Track No User Fee
S008 2019-08-19 Normal 180 Day Track No User Fee
S007 2017-12-21 Normal 180 Day Track No User Fee
S006 2017-12-18 30-day Notice
S005 2017-09-29 Normal 180 Day Track
S004 2017-09-29 30-day Notice
S003 2017-02-03 Special (immediate Track)
S002 2016-07-29 Normal 180 Day Track No User Fee
S001 2016-07-29 Normal 180 Day Track No User Fee

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