COGMEDIX

FDA Device Registration & Listing · West Boylston, MA, US · Registration 3007712511

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
3007712511
FEI Number
3007712511
Entity Name
COGMEDIX
City/State/Country
West Boylston, MA, US
Establishment Address
127 Hartwell St., West Boylston, MA 01583, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Cogmedix, Inc. (Owner Number: 10027034)
Owner / Operator Contact Address
127 Hartwell St., West Boylston, MA 01583, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use Clinical Chemistry Class 1 862.2050 2024-08-23
PKT Laser For Disruption Of Adipocyte Cells For Aesthetic Use General, Plastic Surgery Class 2 878.5400 2022-09-15
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2014-03-18
HCC Device, Biofeedback Neurology Class 2 882.5050 2011-04-07
NUV Massager, Vacuum, Light Induced Heating General, Plastic Surgery Class 2 878.4810 2009-04-27
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2021-08-06
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2022-12-12
IQI Orthosis, Limb Brace Physical Medicine Class 1 890.3475 2014-01-02
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2013-07-23
QAI Powered Microneedle Device General, Plastic Surgery Class 2 878.4430 2019-04-22
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2018-12-14
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2024-08-22
PKT Laser For Disruption Of Adipocyte Cells For Aesthetic Use General, Plastic Surgery Class 2 878.5400 2017-10-05
IRT Pad, Heating, Powered Physical Medicine Class 2 890.5740 2024-02-15
QNK Optoacoustic Imaging System Unknown Class 3 N/A 2022-02-26
ONG Powered Laser Surgical Instrument With MicrobeamFractional Output General, Plastic Surgery Class 2 878.4810 2017-09-19
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2017-09-19

Official Correspondent

Scott Cook

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cogmedix, Inc.
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
K083258 Dornier Medtech America, Inc. MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE 2009-01-30
K201111 Candela Corporation GentleMax Pro Plus 2020-05-26
K202758 Shangdong Huamei Technology Co., Ltd. Nd: YAG Laser Therapy Systems HM-YL900 2020-11-16
K904068 Luxar Corp. LUXAR MODEL LX-20 CO2 LASER 1991-04-15
K142225 CAO Group, Inc. Pilot Elite Diode Laser 2014-09-12

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, 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007712511. Last updated year: 2026. Please use registration number 3007712511 when referencing this establishment in official correspondence.
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