Facility

CUTERA, INC.

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

Key facts

1recalls · worst Class II

2inspections · worst VAI

1warning letters

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

FDA Establishment Identifier (FEI)	3002900199
Establishment type	Manufacture Medical Device
Location	3240 BAYSHORE BLVD BRISBANE, CA, US 94005
Registration status	Active · expires 2026
Parent company	Cutera, Inc. (owner-operator 9038697)
Brand names	Titan XL

Activity by year

Recalls (1)
Inspections (2)
Warning letters (1)

Devices registered here (1)

Lamp, Infrared, Therapeutic Heating
Product code ILY (opens in a new tab) · Class II · Physical Medicine · 21 CFR 890.5500

Recalls & enforcement

Class IITerminated2013-10-16
Cutera received two adverse events associated with the edge of the electrode, when it was pressed against neck skin over the thyroid cartilage and due to the absence of adequate underlying conductive tissue, increased skin heating occurred. Both patients developed linear welts an…

FDA inspections (2)

NAI2017-03-15
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2016-08-19
Voluntary Action Indicated · Bioresearch Monitoring

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.

FDA warning letters (1)

Warning Letter2022-11-10
Warning Letter (opens in a new tab) · Brisbane California

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by Cutera, 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. “CUTERA, INC. (FEI 3002900199) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002900199-cutera-inc/

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