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Breo

FDA UDI

Class II (US FDA UDI)

by Shenzhen Breo Technology Co., Ltd.

Identity

Trade Name
Breo FDA UDI
Generic Name
Hair growth laser device FDA UDI
Device Name
Breo Laser Hair Growth Comb FDA UDI
Model / Reference
Scalp 3L FDA UDI
Description
Breo Laser Hair Growth Comb FDA UDI

Identifiers

Primary DI / UDI-DI
06975488665482 FDA UDI
510(k) Number
K242620 FDA UDI
FDA Product Code
OAP FDA UDI
ISA FDA UDI
GMDN Term
Hair growth laser device FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5500 FDA UDI
890.5660 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

Yes

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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Hair growth laser device

Breo by Shenzhen Breo Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hair growth laser device.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shenzhen Breo Technology Co., Ltd.

Sources (1)

  • FDA UDI 68c6ed49-dc73-4775-9b39-6aff33a10821 34 fields · synced Jun 8, 2026