FacilityLedger

Device establishmentActive, RegisteredFDA warning letter on file

CUTERA, INC.

CUTERA, INC. is an FDA-registered device establishment (FEI 3002900199) located in BRISBANE, California. The facility is active, registered. Its most recent FDA inspection on record (2017-03-15) was classified NAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Feb 8, 2023
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Read the letter on FDA.gov ›

A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.

Recalls (1)

Oct 16, 2013 Class II
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
TerminatedView source data ›

Recall data from openFDA enforcement reports (FDA Recall Enterprise System).

Establishment record

FEI Number
3002900199
Address
3240 BAYSHORE BLVD, BRISBANE, California
Establishment type
Device establishment
Products / operations
General, Plastic Surgery, Manufacture Medical Device, Physical Medicine, Manufacture Medical Device for Another Party (Contract Manufacturer)
Registration status
Active, Registered

Verify this record in FDA source data ›

Inspection history

Inspections on file
Mar 15, 2017 · No Action Indicated (NAI)
Aug 19, 2016 · Voluntary Action Indicated (VAI)
Mar 25, 2014 · Voluntary Action Indicated (VAI)
Mar 25, 2014 · No Action Indicated (NAI)
Nov 5, 2012 · No Action Indicated (NAI)
Aug 30, 2011 · Voluntary Action Indicated (VAI)
Aug 30, 2011 · No Action Indicated (NAI)
Form 483 observations
Mar 25, 2014, 1 observation: Software validation for automated processes
Aug 30, 2011, 5 observations: Time to report - 10 days; Failure to use FDA Form 3500A; Training - Lack of or inadequate procedures

FDA record timeline

Warning letter
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Source ›
FDA inspection
NAI classification
FDA inspection
VAI classification
FDA inspection
VAI classification
FDA inspection
NAI classification
Form 483
1 observation
Recall
Class II — 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
Source ›
FDA inspection
NAI classification
FDA inspection
VAI classification
FDA inspection
NAI classification
Form 483
5 observations

Combined chronology of the public records shown on this page. FDA coverage varies by dataset and year.

Questions

Is CUTERA, INC. registered with the FDA?

Yes. CUTERA, INC. is an FDA-registered device establishment (FEI 3002900199) in BRISBANE, California. Its current registration status is Active, Registered.

Has CUTERA, INC. received an FDA warning letter?

Yes. FDA issued a warning letter to CUTERA, INC.; the most recent is dated Feb 8, 2023 (Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device).

What does CUTERA, INC. do?

CUTERA, INC.'s FDA-registered operations are: General, Plastic Surgery, Manufacture Medical Device, Physical Medicine, Manufacture Medical Device for Another Party (Contract Manufacturer).

Related facilities

Westwood Laboratories, LLC.KC Pharmaceuticals, Inc.Sanitor CorporationImmunityBio, Inc.CellEra, LLCBECKMAN COULTER, INC.

Source: FDA public data · status as of 2026-08-22

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