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: Pistachio 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: 07350120791764 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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

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

Similar devices

Also classified as Blue-light phototherapy lamp, home-use.

Sapphire — Omm Imports Inc. · Class II
Elevare Ivory — Omm Imports Inc. · Class II
CLEANE — Medicon Co., Ltd. · Class II
Sapphire X — Omm Imports Inc. · Class II
Positively Clear — TRIA LASER INC · Class II
LS Pro Systems — WELLNESS WITHOUT LIMITS LLC · Class II
Genesis Skye — Omm Imports Inc. · Class II
LS Pro Systems — WELLNESS WITHOUT LIMITS LLC · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Foreo Inc

Sources (1)

FDA UDI 50bef319-8af3-40e3-bdcc-b9a1c41d6961 34 fields · synced May 29, 2026