Recreo

FDA UDI

Class II (US FDA UDI)

by Omm Imports Inc.

Identity

Trade Name: Recreo FDA UDI
Generic Name: Hair growth laser device FDA UDI
Device Name: Over the counter laser/led device for hair growth. FDA UDI
Model / Reference: R200 FDA UDI
Description: Over the counter laser/led device for hair growth. FDA UDI

Identifiers

Primary DI / UDI-DI: 00850001456067 FDA UDI
FDA Product Code: OAP FDA UDI
GMDN Term: Hair growth laser device 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Hair growth laser device

Recreo by Omm Imports Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Hair growth laser device.

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Diode Laser Cap — Cosmo Far East Technology Limited · Class II
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HairMax — Lexington International, LLC · Class II
RedRestore — 10589578 Canada Inc. · Class II
Hairmax — Lexington International, LLC · Class II
HairMax — Lexington International, LLC · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Omm Imports Inc.

Sources (1)

FDA UDI 159785d6-4393-4c7f-b6e7-2ee1de14d025 34 fields · synced Jun 1, 2026