Lutronic Aesthetics, Inc.

FDA Device Registration & Listing · Westford, MA, US · Registration 3006247712

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006247712
FEI Number
3006247712
Entity Name
Lutronic Aesthetics, Inc.
City/State/Country
Westford, MA, US
Establishment Address
3/5 Carlisle Road, Westford, MA 01886, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Lutronic Aesthetics, Inc. (Owner Number: 9058403)
Owner / Operator Contact Address
3/5 Carlisle Road, Westford, MA 01886, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K244060
PMA Number
N/A

All Registered Proprietary Names

XERF eCO2 3D

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-08-15
ONG Powered Laser Surgical Instrument With MicrobeamFractional Output General, Plastic Surgery Class 2 878.4810 2025-08-06
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2025-08-06

Official Correspondent

Sean Reynolds

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Lutronic Aesthetics, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3043532708 Cynosure Lutronic Technology Corporation Daegu Gyeongbuk, KR
3033511105 Cynosure Lutronic Technology Corporation Goyang Gyeonggi, KR
3023706404 Lutronic Corporation Daegu Gyeongbuk, KR
3013789508 Lutronic Corporation Goyang-si Gyeonggi, KR
3004483538 LUTRONIC CORPORATION Goyang-si Gyeonggi, KR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19
K193591 Bowa-Electronics GmbH & Co. KG ARC 400 2020-04-02
K192128 Sutter Medizintechnik GmbH Sutter Arrowtip Monopolar Electrodes 2019-10-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-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

Similar Registrations

Registration Number Establishment Name Location
3007353760 ENERGIST LIMITED Swansea, GB
3005064998 RDI INC. Mount Kisco, NY, US
3020623326 TRIWORKS GROUP S.R.L. Palata Campobasso, IT
3012616488 BRERA MEDICAL INCORPORATED Northborough, MA, US
3012940012 Sutter Medical Technologies USA Inc. Alpharetta, GA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006247712. Last updated year: 2026. Please use registration number 3006247712 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.