Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013481783

FEI Number

3013481783

Entity Name

I-SMART Development LTD.

City/State/Country

Sutton Coldfield Birmingham, GB

Establishment Address

129, Green lanes, Wylde Green, Sutton Coldfield Birmingham B73 5LT, GB

Establishment Type(s)

Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

I-smart marketing/development LTD. (Owner Number: 10061409)

Owner / Operator Contact Address

129, Green lanes, Wylde Green, Sutton Coldfield, GB-BIR B73 5LT, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213184

PMA Number

N/A

All Registered Proprietary Names

Omnilux Contour Neck and Decollete UnveiLED Neck & Decollete handLITE UNveiLED Glove decoLITE RIO Dermapenworld Neck and Decollete Omnilux Contour Glove decoLITE Dermapenworld LED Hand C-WAVE LED MASK FOR NECK & DECOLLETE handLITE Omnilux Contour Glove LightMAX MiniPro Eyeconic Omnilux Mini Blemish Eraser LUMA Blemish Omnilux Mini Skin Corrector SkinLED LUMA Bright Smoothskin DuoLux Mini Collagen+ LUMA Revive Omnilux Mini Eye Brightener Eye Regenerate Omnilux CLEAR decoLITE decoLITE RIO Omnilux Contour Neck and Decollete UnveiLED Neck & Decollete Dermapenworld Neck and Decollete C-WAVE LED MASK FOR NECK & DECOLLETE MZ Skin LightMAX Supercharged LED Mask 2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2019-12-15
ONE	Powered Light Based Non-Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2025-08-24
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2023-09-15
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2023-09-15
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2021-07-03
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2024-11-19
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2021-11-30
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2021-11-30

Official Correspondent

Susan D'Arcy

US Agent Details

Steven Baker Business: i-SMART Consulting US LLC Email: s.baker.ismart@gmail.com Phone: (267) 4321045

Related Public Records

Same Entity

I-smart marketing/development LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013481783. Last updated year: 2026. Please use registration number 3013481783 when referencing this establishment in official correspondence.