CAO (CHINA) MEDICAL EQUIPMENT COMPANY, LIMITED

FDA Device Registration & Listing · LANGFANG, HEBEI, CN · Registration 3004475754

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
3004475754
FEI Number
3004475754
Entity Name
CAO (CHINA) MEDICAL EQUIPMENT COMPANY, LIMITED
City/State/Country
LANGFANG, HEBEI, CN
Establishment Address
NO. 19 BAIHE ROAD, LANGFANG ETDZ, LANGFANG, HEBEI 065001, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device
Owner / Operator
CAO Group, Inc. (Owner Number: 9043755)
Owner / Operator Contact Address
4628 West Skyhawk Drive, West Jordan, UT 84084, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K092616
PMA Number
N/A

All Registered Proprietary Names

Picasso Pro Diode Laser Visco Tip Liqua Tip FE Scrub Tip FastFix LEAP Cavity Cleansing Solution BlissBond BlissEtch

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NVK Laser, Dental, Soft Tissue General, Plastic Surgery Class 2 878.4810 2026-03-25
EEG Heat Source For Bleaching Teeth Dental Class 1 872.6475 2026-03-25
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2026-03-25
KXR Applicator, Resin Dental Class 1 872.3140 2018-09-14
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2009-12-22
LBH Varnish, Cavity Dental Class 2 872.3260 2007-11-07
LBH Varnish, Cavity Dental Class 2 872.3260 2009-12-22
KLE Agent, Tooth Bonding, Resin Dental Class 2 872.3200 2009-12-22

Official Correspondent

Robert Larsen

US Agent Details

ROB LARSEN Business: CAO GROUP, INC. Email: rob.larsen@caogroup.com Phone: (801) 2569282

Related Public Records

Same Entity

CAO Group, 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
1725006 CAO GROUP, INC. W Jordan, UT, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K142225 CAO Group, Inc. Pilot Elite Diode Laser 2014-09-12
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
Z-0035-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008 Heraeus Kulzer Inc., Dental Products Division 2
Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.

Similar Registrations

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1032227 BRASSELER U.S.A. DENTAL, LLC SAVANNAH, GA, US
3005515469 DENTLIGHT INC. Plano, TX, US
1725006 CAO GROUP, INC. W Jordan, UT, US
3005972890 GoldenDent Roseville, MI, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004475754. Last updated year: 2026. Please use registration number 3004475754 when referencing this establishment in official correspondence.
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