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Ellex

FDA UDI

Class II (US FDA UDI)

by Ellex Medical Pty Ltd

Identity

Trade Name
Ellex FDA UDI
Generic Name
Ophthalmic solid-state laser system, photodisruption FDA UDI
Device Name
ACC, TONOMETER POST, HAAG STREIT 900BM FDA UDI
Model / Reference
6335740 FDA UDI
Description
ACC, TONOMETER POST, HAAG STREIT 900BM FDA UDI

Identifiers

Primary DI / UDI-DI
09342395000625 FDA UDI
510(k) Number
K081565 FDA UDI
FDA Product Code
HQF FDA UDI
GMDN Term
Ophthalmic solid-state laser system, photodisruption 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

No

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

Yes

FDA UDI

Category: Ophthalmic solid-state laser system, photodisruption

Ellex by Ellex Medical Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ophthalmic solid-state laser system, photodisruption.

Cleared under the same submission

K081565 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ellex Medical Pty Ltd

Sources (1)

  • FDA UDI 6418614d-54ad-4435-9e7e-37b61f4e4604 35 fields · synced Jun 8, 2026