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Elita

FDA UDI

Class II (US FDA UDI)

by Johnson & Johnson Surgical Vision, Inc.

Identity

Trade Name
ELITA FDA UDI
Generic Name
Femtosecond ophthalmic solid-state laser system FDA UDI
Device Name
ELITA FEMTOSECOND LASER FDA UDI
Model / Reference
EL2022 FDA UDI
Description
ELITA FEMTOSECOND LASER FDA UDI

Identifiers

Catalog Number
0155-1001 FDA UDI
Primary DI / UDI-DI
05050474738553 FDA UDI
FDA Product Code
OOE FDA UDI
GMDN Term
Femtosecond ophthalmic solid-state laser system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
886.4390 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Femtosecond ophthalmic solid-state laser system

Elita by Johnson & Johnson Surgical Vision, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Femtosecond ophthalmic solid-state laser system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Johnson & Johnson Surgical Vision, Inc.

Sources (1)

  • FDA UDI 204254a0-d990-40ca-86bb-80af09080459 35 fields · synced Jun 9, 2026