Inlay Inserter Chuck Handle

FDA UDI

Class III (US FDA UDI)

by Revision Optics, Inc.

Identity

Trade Name: Inlay Inserter Chuck Handle FDA UDI
Generic Name: Ophthalmic surgical instrument handle, manual FDA UDI
Device Name: The Inlay Inserter Chuck Handle is used in conjunction with the Inlay Inserter to extend the length of the device for ease of use while delivering the Raindrop® Near Vision Inlay. The Inserter Handle has three components: the handle, the sleeve, and the chuck. FDA UDI
Model / Reference: 607-0002 FDA UDI
Description: The Inlay Inserter Chuck Handle is used in conjunction with the Inlay Inserter to extend the length of the device for ease of use while delivering the Raindrop® Near Vision Inlay. The Inserter Handle has three components: the handle, the sleeve, and the chuck. FDA UDI

Identifiers

Catalog Number: 607-0002 FDA UDI
Primary DI / UDI-DI: 10850394006051 FDA UDI
PMA Number: P150034 FDA UDI
FDA Product Code: LQE FDA UDI
GMDN Term: Ophthalmic surgical instrument handle, manual FDA UDI

Classification

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

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Ophthalmic surgical instrument handle, manual

Inlay Inserter Chuck Handle by Revision Optics, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

P150034 also covers:

Raindrop Near Vision Inlay — REVISION OPTICS, INC.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class III	Pending data

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Manufacturer

Manufacturer: Revision Optics, Inc.

Sources (1)

FDA UDI 4bcb5c74-d5ed-4708-961d-df887e9282ba 37 fields · synced Jun 8, 2026