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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
Laser beam eye protector, patient FDA UDI
Device Name
ACC. SPECTACLES, SAFETY, 523nm & 1064nm (TANGO) FDA UDI
Model / Reference
6328990 FDA UDI
Description
ACC. SPECTACLES, SAFETY, 523nm & 1064nm (TANGO) FDA UDI

Identifiers

Primary DI / UDI-DI
09342395000588 FDA UDI
510(k) Number
K021550 FDA UDI
K041598 FDA UDI
K122202 FDA UDI
K992824 FDA UDI
FDA Product Code
GEX FDA UDI
HQF FDA UDI
GMDN Term
Laser beam eye protector, patient FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4810 FDA UDI
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: Laser beam eye protector, patient

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

Similar devices

Also classified as Laser beam eye protector, patient.

Cleared under the same submission

K021550 also covers:

K041598 also covers:

K992824 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 a448e94b-c8a2-443e-8f6d-8b5596fcbaa0 35 fields · synced Jun 1, 2026