Facility

BEIJING SYNTECH LASER CO., LTD.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

1inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3007535734
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	4/F West Area,1#Building Beijing, CN 10220
Registration status	Active · expires 2026
Parent company	Beijing Syntech Laser Co., Ltd. (owner-operator 10036444)
Brand names	PiXel8-RF

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (2)

Skin Resurfacing Rf Applicator
Product code OUH (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4400
Electrosurgical, Cutting & Coagulation & Accessories
Product code GEI (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4400

Recalls & enforcement

Class IIOngoing2017-07-03
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".

FDA inspections (1)

VAI2017-07-07
Voluntary Action Indicated · Compliance: Devices; Radiation Control and Health Safety Act · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Beijing Syntech Laser Co., Ltd.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “BEIJING SYNTECH LASER CO., LTD. (FEI 3007535734) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007535734-beijing-syntech-laser-co-ltd/

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