Facility

Strata Skin Sciences, inc.

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

Key facts

1recalls · worst Class II

4inspections · 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)	3002942014
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	2375 Camino Vida Roble Carlsbad, CA, US 92011
Registration status	Active · expires 2026
Parent company	STRATA Skin Sciences, INC. (owner-operator 9036949)
Brand names	XTRAC Excimer Laser Phototherapy System Model No. AL10000; XTRAC; XTRAC Excimer Laser Phototherapy System

Activity by year

Recalls (1)
Inspections (4)

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 IITerminated2017-01-23
When the Liquid Guide ( LLG) is not used according to the operator manual, the switch control wires may become loose and shorted. Shorted wires may lead to unintentional laser firing.

FDA inspections (4)

VAI2024-08-22
Voluntary Action Indicated · Compliance: Devices; Radiation Control and Health Safety Act; Postmarket Assurance: Devices · citations posted
NAI2021-09-30
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2019-02-21
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act · citations posted
VAI2016-12-16
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: 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 STRATA Skin Sciences, INC.

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. “Strata Skin Sciences, inc. (FEI 3002942014) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002942014-strata-skin-sciences-inc/

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