Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018188770

FEI Number

3018188770

Entity Name

Lustre Skin Ltd

City/State/Country

Livingston Scotland, GB

Establishment Address

Alba Innovation Centre, Alba Campus, Livingston Scotland EH54 7GA, GB

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Lustre Skin Ltd (Owner Number: 10080478)

Owner / Operator Contact Address

Alba Innovation Centre, Alba Campus, Livingston, GB-SCT EH54 7GA, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K143713

PMA Number

N/A

All Registered Proprietary Names

LUSTRESTRIPS Mini Strips LUSTRESTRIPS LUSTRESTRIPS Mini Dots LUSTRE ClearSkin RENEW Pro Facewear Mask Facegym Lightwear LED Face Mask LUSTRE ClearSkin SOLO LUSTRE ClearSkin TRIO Facegym Acne Light Shot

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2023-05-30
OHS	Light Based Over The Counter Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4810	2023-04-06
OLP	Over-The-Counter Powered Light Based Laser For Acne	General, Plastic Surgery	Class 2	878.4810	2023-04-06
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2021-02-04

Official Correspondent

Blessing Nwabude

US Agent Details

Kristi Leigh Business: Smith Associates Email: kleigh@fdaconsultants.com Phone: (888) 7299674

Related Public Records

Same Entity

Lustre Skin Ltd

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

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3012453673	FANNIN (UK) LIMITED	Measham, Swadlincote Derbyshire, GB
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018188770. Last updated year: 2026. Please use registration number 3018188770 when referencing this establishment in official correspondence.