Solarc/SolRx E-Series

FDA UDI

Class II (US FDA UDI)

by Solarc Systems Inc

Identity

Trade Name: Solarc/SolRx E-Series FDA UDI
Generic Name: Ultraviolet phototherapy unit, home-use FDA UDI
Device Name: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx E-Series 6-foot 6-Bulb UVB-Narrowband ADD-ON device, Expandable/Modular & Multi-directional Full Body Panels. Indications for Use: Psoriasis, Vitiligo, Atopic Dermatitis (Eczema). FDA UDI
Model / Reference: E760A-UVBNB FDA UDI
Description: Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx E-Series 6-foot 6-Bulb UVB-Narrowband ADD-ON device, Expandable/Modular & Multi-directional Full Body Panels. Indications for Use: Psoriasis, Vitiligo, Atopic Dermatitis (Eczema). FDA UDI

Identifiers

Primary DI / UDI-DI: B219E760AUVBNB0 FDA UDI
510(k) Number: K103204 FDA UDI
FDA Product Code: FTC FDA UDI
GMDN Term: Ultraviolet phototherapy unit, home-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4630 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

Yes

FDA UDI

Over-the-Counter

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

FDA UDI

Category: Ultraviolet phototherapy unit, professional Ultraviolet phototherapy unit, home-use

Solarc/SolRx E-Series by Solarc Systems Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

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: Solarc Systems Inc

Sources (1)

FDA UDI 90d3b775-5ffe-4461-834e-1ccca949a7b0 34 fields · synced May 30, 2026