Facility

XINTEC CORPORATION

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

Key facts

2recalls · worst Class II

2inspections · 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)	2938889
Establishment type	Manufacture Medical Device
Location	1660 SOUTH LOOP ROAD ALAMEDA, CA, US 94502
Registration status	Active · expires 2026
Parent company	XINTEC CORPORATION DBA CONVERGENT LASER TECHNOLOGIES (owner-operator 2938889)
Brand names	Optica XT Thulium Fiber Laser and Accessories

Activity by year

Recalls (2)
Inspections (2)

Devices registered here (1)

Powered Laser Surgical Instrument
Product code GEX (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4810

Recalls & enforcement

Class IIITerminated2017-10-29
It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the fibers from this lot will produce an error and will not allow the user to use the laser when it is plugged in.
Class IITerminated2017-06-23
It has been determined that the reprocessing instructions may not provide sufficiently detailed information for the cleaning, disinfection and sterilization of the products listed below. The preliminary investigation indicates that validation data related to the reprocessing of t…

FDA inspections (2)

VAI2022-06-07
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act · citations posted
NAI2016-09-13
No Action Indicated · Compliance: Devices; Radiation Control and Health Safety Act; Postmarket Assurance: Devices · 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 XINTEC CORPORATION DBA CONVERGENT LASER TECHNOLOGIES

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. “XINTEC CORPORATION (FEI 2938889) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2938889-xintec-corporation/

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