Raindrop Near Vision Inlay

Implant, Corneal, Refractive

FDA Premarket Approval P150034 S007

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 for proposed reporting changes to the post-approval study (pas) protocol.

• Device: Raindrop Near Vision Inlay
• Classification Name: Implant, Corneal, Refractive
• Generic Name: Implant, Corneal, Refractive
• Applicant: RVO 2.0, Inc. (d.b.a. Optics Medical)
• Date Received: 2017-12-21
• Decision Date: 2018-02-15
• PMA: P150034
• Supplement: S007
• Product Code: LQE
• Advisory Committee: Ophthalmic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - Ode/oir
• Expedited Review: No
• 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 Number	Date	Supplement Type
P150034		Original 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

NIH GUDID Devices

Device ID	PMA	Supp
10850394006051	P150034	000