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Gigaa

FDA UDI

Class II (US FDA UDI)

by Gigaalaser Company Ltd.

Identity

Trade Name
GIGAA FDA UDI
Generic Name
Musculoskeletal infrared phototherapy unit, non-wearable FDA UDI
Device Name
Physical therapy FDA UDI
Model / Reference
GBOX-20B FDA UDI
Description
Physical therapy FDA UDI

Identifiers

Primary DI / UDI-DI
16977331780011 FDA UDI
510(k) Number
K242755 FDA UDI
FDA Product Code
ILY FDA UDI
GMDN Term
Musculoskeletal infrared phototherapy unit, non-wearable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5500 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Musculoskeletal infrared phototherapy unit, non-wearable

Gigaa by Gigaalaser Company Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Musculoskeletal infrared phototherapy unit, non-wearable.

Cleared under the same submission

K242755 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gigaalaser Company Ltd.

Sources (1)

  • FDA UDI e4a67acf-ca81-49b6-96d0-d193458a7c04 34 fields · synced Jun 1, 2026