Beijing Syntech Laser Co., Ltd.
Manufacturer and brand owner in Beijing, China. 5 device types, 8 products catalogued, 3 clearances.
Beijing Syntech Laser Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Fat Reducing Low Level Laser, Skin Resurfacing Rf Applicator and 3 other device types. 8 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2019.
5device types registered with the FDA
8products catalogued under its own name
3510(k) clearances
8recalls
Registration
| Registered name | BEIJING SYNTECH LASER CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007535734 |
| FEI number | 3007535734 |
| DUNS | 528741132 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 北京信天嘉华科技发展有限公司 |
|---|---|
| Unified social credit code | 91110108778647825N |
| Source | NMPA UDI database |
Location
| City | Beijing |
|---|---|
| Province | Beijing |
| Address | 4/F West Area,1#Building |
| Postal code | 102206 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | Class 2 | Pix-E, PiXel8-RF | 2019 | 65 |
| Fat Reducing Low Level Laser | Class 2 | UltraLight LED | 2025 | 6 |
| Powered Laser Surgical Instrument | Class 2 | Epilaze, Pix-E, PicoLazer, UltraLight LED, spectrum | 2025 | 92 |
| Skin Resurfacing Rf Applicator | Class 2 | Pix-E, PiXel8-RF | 2019 | 2 |
| Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | Class 2 | Futura Pro (US Specification) | 2021 | 4 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Powered Laser Surgical Instrument Apollo IV+ Medical Platform | GEX | 2 |
| Powered Laser Surgical Instrument-UL CO2 Laser | GEX | 1 |
| Powered Laser Surgical Instrument Trixel CO2 Laser | GEX | 1 |
| Powered Laser Surgical Instrument-Diode Laser Model | GEX | 1 |
| Powered Laser Surgical Instrument Nice Station Light Based Platform | GEX | 1 |
| Powered Laser Surgical Instrument-Trixel II CO2 Laser | GEX | 1 |
| Powered Laser Surgical Instrument-Diode Laser | GEX | 1 |
| Powered Laser Surgical Instrument Apollo V+ Medical Platform | GEX | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K123483 | 2013-04-21 | GEX | Traditional | This company |
| K113018 | 2012-12-14 | GEX | Traditional | This company |
| K110434 | 2011-04-19 | GEX | Traditional | This company |
Recalls
8 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2017-07-03 | Class II | Nonconforming Material/Component | The noncompliance is that the certification label was not affixed on the product, with statement “Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007″. | 3 |
| 2017-07-03 | Class II | Nonconforming Material/Component | The noncompliance is that the certification label was not affixed on the product, with statement “Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007″. | 92 |
| 2017-07-03 | Class II | Nonconforming Material/Component | The noncompliance is that the certification label was not affixed on the product, with statement “Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007″. | 199 |
| 2017-07-03 | Class II | Nonconforming Material/Component | The noncompliance is that the certification label was not affixed on the product, with statement “Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007″. | 11 |
| 2017-07-03 | Class II | Nonconforming Material/Component | The noncompliance is that the certification label was not affixed on the product, with statement “Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007″. | 13 |
| 2017-07-03 | Class II | Nonconforming Material/Component | The noncompliance is that the certification label was not affixed on the product, with statement “Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007″. | 38 |
| 2017-07-03 | Class II | Nonconforming Material/Component | The noncompliance is that the certification label was not affixed on the product, with statement “Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007″. | 6 |
| 2017-07-03 | Class II | Nonconforming Material/Component | The noncompliance is that the certification label was not affixed on the product, with statement “Complies with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 50, dated June 24, 2007″. | 7 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2002 |
|---|---|
| Main products | IPL, RF, lasers, vacuum, medical aesthetic equipment |
| Certifications | FDA |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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