BEIJING SPIRITLASER SCIENCE & TECHNOLOGY CO., LTD.

FDA Device Registration & Listing · Beijing, CN · Registration 3017132875

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
3017132875
FEI Number
3017132875
Entity Name
BEIJING SPIRITLASER SCIENCE & TECHNOLOGY CO., LTD.
City/State/Country
Beijing, CN
Establishment Address
2-813, Floor 8, Building 1, Yard 56, Fuqian Street, Beijing 101300, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Beijing Spiritlaser Science & Technology Co., Ltd. (Owner Number: 10092055)
Owner / Operator Contact Address
2-813, Floor 8, Building 1, Yard 56, Fuqian Street, Beijing, CN-BJ 101300, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

LED machines LED facial mask RF Machine:HF009, S11, HF006.HF007.EMS-10.EMS-20.EMS-16.S7 Plasma pen:Plasma pen HIFU Hydra Facial Machine EMS SCULPTING EMS face machine Small bubble Velasmooth Inner Ball Shockwave Therapy System Vacuum Therapy Machine:S11, S6, HF009 Hydra oxygen facial machine Picosecond Laser Tattoo Removal System Dermatological Diode Laser Systems Cryolipolysis Slimming Machine Skin analyzer Cavitation Lipolaser vacuum system machine Fractional co2 laser system Co2 Fractional Laser MNRF DEPTH 8 Fractional RF Microneedling System ELECTRONIC MUSCLE STIMULATOR

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use Clinical Chemistry Class 1 862.2300 2024-11-28
PAY Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction General, Plastic Surgery Class 2 878.4420 2026-01-03
HRP Pen, Marking, Surgical Ophthalmic Class 1 886.4570 2026-01-03
PZC Ablation System, High Intensity Focus Ultrasound (Hifu), Soft Tissue Unknown Class N N/A 2024-11-28
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2024-11-28
NUV Massager, Vacuum, Light Induced Heating General, Plastic Surgery Class 2 878.4810 2024-11-28
PZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers General, Plastic Surgery Class 2 878.4685 2024-11-28
OOK Dermal Cooling Pack/Vacuum/Massager General, Plastic Surgery Class 2 878.4340 2026-01-03
GFE Brush, Dermabrasion, Powered General, Plastic Surgery Class 1 878.4820 2024-11-28
QHF Energy Based Device For Treatment Of Tattoos General, Plastic Surgery Class 2 878.4810 2024-11-28
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2026-01-03
OUP Powered Surgical Instrument For Improvement In The Appearance Of Cellulite General, Plastic Surgery Class 2 878.4790 2024-11-28
HCJ Device, Skin Potential Measurement Neurology Class 2 882.1560 2024-11-28
OLI Fat Reducing Low Level Laser General, Plastic Surgery Class 2 878.5400 2024-11-28
ONG Powered Laser Surgical Instrument With MicrobeamFractional Output General, Plastic Surgery Class 2 878.4810 2024-11-28
NXF Gas, Laser Generating General, Plastic Surgery Class 1 878.4810 2024-11-28
QAI Powered Microneedle Device General, Plastic Surgery Class 2 878.4430 2024-11-28
NGX Stimulator, Muscle, Powered, For Muscle Conditioning Physical Medicine Class 2 890.5850 2025-02-24

Official Correspondent

Junping Yang

US Agent Details

Yuan Dan Email: service20210328@hotmail.com Phone: (805) 3513025

Related Public Records

Same Entity

Beijing Spiritlaser Science & Technology Co., 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
K760232 Instrumentation Laboratory CO PRINTER, IL 460 1976-08-26
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 3017132875. Last updated year: 2026. Please use registration number 3017132875 when referencing this establishment in official correspondence.
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