Poly

FDA UDI

Class II (US FDA UDI)

by Medtek Lighting Corp

Identity

Trade Name: POLY FDA UDI
Generic Name: Blue/red/infrared phototherapy lamp FDA UDI
Device Name: LED Light Therapy Device. Uses 1820 LEDs. LEDs may be Red (633nm), Blue (415nm) and/or Infrared (850nm). The wavelengths are available individually on treatment heads or a mix of wavelengths on the same treatment head. There is a Touch Screen Display for entering treatment times and selecting treatment heads. The unit is mounted on a base with casters for moving around a clinic. FDA UDI
Model / Reference: 7000A FDA UDI
Description: LED Light Therapy Device. Uses 1820 LEDs. LEDs may be Red (633nm), Blue (415nm) and/or Infrared (850nm). The wavelengths are available individually on treatment heads or a mix of wavelengths on the same treatment head. There is a Touch Screen Display for entering treatment times and selecting treatment heads. The unit is mounted on a base with casters for moving around a clinic. FDA UDI

Identifiers

Primary DI / UDI-DI: B3437000A1 FDA UDI
510(k) Number: K170187 FDA UDI
FDA Product Code: GEX FDA UDI
GMDN Term: Blue/red/infrared phototherapy lamp 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

Yes

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

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Area/Surface Area — 800 Square centimeter FDA UDI
Weight — 60 Pound FDA UDI

Category: Blue/red/infrared phototherapy lamp

Poly by Medtek Lighting Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blue/red/infrared phototherapy lamp.

Dermalux — Aesthetic Technology, Ltd. · Class II
Celluma — BioPhotas, Inc. · Class II
reVive Light Therapy® — LED TECHNOLOGIES, INC. · Class II
Dr Dennis Gross Skincare — LED TECHNOLOGIES, INC. · Class II
LESCOLTON — Shenzhen Lescolton Medical Equipment Co., Ltd. · Class II
Platinum LED Therapy Lights — PLATINUM LED HOLDINGS LLC · Class II
LESCOLTON — Shenzhen Lescolton Medical Equipment Co., Ltd. · Class II
Platinum LED Therapy Lights — PLATINUM LED HOLDINGS 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: Medtek Lighting Corp

Sources (1)

FDA UDI 7719b4d5-eb9d-4f81-99ec-03b2f859e073 36 fields · synced May 31, 2026