BLINK BRIGHT MEDICAL, INC.

FDA Device Registration & Listing · Houston, TX, US · Registration 3043047259

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
3043047259
FEI Number
3043047259
Entity Name
BLINK BRIGHT MEDICAL, INC.
City/State/Country
Houston, TX, US
Establishment Address
5252 Hollister St Ste 318, Houston, TX 77040, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Blink Bright Medical, Inc. (Owner Number: 10095007)
Owner / Operator Contact Address
5252 Hollister Street, Suite 318, Houston, TX 77040, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K190936
PMA Number
N/A

All Registered Proprietary Names

ZenLight Zen1550 ZenFX ZenPico ZenSculpt ZenDiode HR Zen980 ZenQ

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect General, Plastic Surgery Class 2 878.4810 2026-01-14
ONG Powered Laser Surgical Instrument With MicrobeamFractional Output General, Plastic Surgery Class 2 878.4810 2026-01-14
ONG Powered Laser Surgical Instrument With MicrobeamFractional Output General, Plastic Surgery Class 2 878.4810 2026-01-14
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2026-01-14
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2026-01-14
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2026-01-14
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2026-01-14
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2026-01-14

Official Correspondent

Robert Ohlund

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Blink Bright Medical, 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
K192521 Shangdong Huamei Technology Co., Ltd. Intense Pulsed Light Treatment System 2019-12-06
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

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 3043047259. Last updated year: 2026. Please use registration number 3043047259 when referencing this establishment in official correspondence.
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