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Raindrop Near Vision Inlay

FDA UDI

Class III (US FDA UDI)

by Revision Optics, Inc.

Identity

Trade Name
Raindrop Near Vision Inlay FDA UDI
Generic Name
Corneal inlay, aperture reducing FDA UDI
Device Name
The Raindrop Near Vision Inlay is a biocompatible hydrogel corneal inlay. It is designed to be implanted under a femtosecond laser flap onto the stromal bed of the cornea, centered over a light-constricted pupil. The Raindrop Near Vision Inlay reshapes the central region of the cornea to provide a zone of increased power for focusing on near objects, resulting in improvement in near vision. The Raindrop Near Vision Inlay is supplied steam sterilized and pre-loaded in its delivery device, the Inlay Inserter. It is for single-use only. FDA UDI
Model / Reference
RD1-1 FDA UDI
Description
The Raindrop Near Vision Inlay is a biocompatible hydrogel corneal inlay. It is designed to be implanted under a femtosecond laser flap onto the stromal bed of the cornea, centered over a light-constricted pupil. The Raindrop Near Vision Inlay reshapes the central region of the cornea to provide a zone of increased power for focusing on near objects, resulting in improvement in near vision. The Raindrop Near Vision Inlay is supplied steam sterilized and pre-loaded in its delivery device, the Inlay Inserter. It is for single-use only. FDA UDI

Identifiers

Catalog Number
RD1-1 FDA UDI
Primary DI / UDI-DI
10850394006013 FDA UDI
PMA Number
P150034 FDA UDI
FDA Product Code
LQE FDA UDI
GMDN Term
Corneal inlay, aperture reducing FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Corneal inlay, aperture reducing

Raindrop Near Vision Inlay by Revision Optics, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

P150034 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Revision Optics, Inc.

Sources (1)

  • FDA UDI 33d476cf-aece-4eb2-bd38-0b6109153394 38 fields · synced May 30, 2026