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Onebeauty

FDA UDI

Class II (US FDA UDI)

by Glan Electronics Co., Ltd.

Identity

Trade Name
ONEBEAUTY FDA UDI
Generic Name
Intense pulsed light skin surface treatment system FDA UDI
Model / Reference
OBT-02 FDA UDI

Identifiers

Primary DI / UDI-DI
06976404770211 FDA UDI
FDA Product Code
OHT FDA UDI
GMDN Term
Intense pulsed light skin surface treatment system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4810 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Intense pulsed light skin surface treatment system

Onebeauty by Glan Electronics Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intense pulsed light skin surface treatment system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Glan Electronics Co., Ltd.

Sources (1)

  • FDA UDI c2946c2e-94e7-4674-9c59-70211a87f2d9 32 fields · synced May 30, 2026