ESPADA 2 Plus

FDA UDI

Class II (US FDA UDI)

by Foreo Inc

Identity

Trade Name: ESPADA 2 Plus FDA UDI
Generic Name: Blue-light phototherapy lamp, home-use FDA UDI
Device Name: ESPADA™ devices have been developed to be used as an at-home devices for the treatment of mild to moderate inflammatory acne on the facial area FDA UDI
Model / Reference: Lavender FDA UDI
Description: ESPADA™ devices have been developed to be used as an at-home devices for the treatment of mild to moderate inflammatory acne on the facial area FDA UDI

Identifiers

Primary DI / UDI-DI: 07350120791757 FDA UDI
510(k) Number: K162450 FDA UDI
FDA Product Code: OLP FDA UDI
GMDN Term: Blue-light phototherapy lamp, home-use 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

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

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Blue-light phototherapy lamp, home-use

ESPADA 2 Plus by Foreo Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K162450 also covers:

ESPADA 2 — FOREO INC
ESPADA 2 — FOREO INC
ESPADA 2 — FOREO INC
ESPADA 2 Plus — FOREO INC
ESPADA Acne-Clearing Blue Light Pen — FOREO INC
ESPADA Acne-Clearing Blue Light Pen — FOREO INC
ESPADA Acne-Clearing Blue Light Pen — FOREO INC

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: Foreo Inc

Sources (1)

FDA UDI c9e3f904-ffc3-4091-911e-5c808d517dde 34 fields · synced May 30, 2026