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Cutera, Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000010456 FEI 3002900199

Cutera, Inc. is a medical device manufacturer based in the United States, with 85 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class IIb) and 2 FDA recalls as of 13 Nov 2026.

Devices
85
Registrations
EUDAMEDFDA
FDA recalls
2

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 58
  • EUDAMED 33
  • FDA 510(k) 27

A device listed in two registries counts in both.

Device classes
  • FDA Class II 61
  • EU Class IIb 24
Top EMDN categories
FDA recalls
Sites and related companies
Identifiers
  • EUDAMED SRN US-MF-000010456
  • FDA FEI 3002900199
  • DUNS 041071643

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
United States
FDA FEI, FDA recalls
Authorised rep.
MDSS GmbHDE

What Cutera, Inc. makes

Cutera, Inc. manufactures dermatological laser and radio-frequency systems for skin and body treatments, including solid-state and frequency-doubled lasers, multi-modality skin surface and contouring systems, and applicators such as handpieces and monopolar RF devices. Their product examples include truSculpt iD, Titan V, CoolView, AviClear, Solera Opus, excel V, CoolGlide CV, ProWave 770, CoolGlide Excel, truSculpt 25, truSculpt 16, and Pearl Fractional Standoffs.

The company's devices are classified as Class II and Class IIb and are listed in regulatory databases including EUDAMED, FDA 510(k), and FDA UDI. Cutera, Inc. is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue85

Newest first, rows 1-50 of 85

Search and filter all 85 devices
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  • truSculpt iD

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:II

  • Titan V

    Listed Registry: GUDID Class:II

  • CoolView

    Active Regimes: 510(k) Registry: GUDID Class:II

  • AviClear

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:II

  • Solera Opus

    Active Regimes: 510(k) Registry: GUDID Class:II

  • excel V

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • CoolGlide CV

    Listed Registry: GUDID Class:II

  • ProWave 770

    Active Regimes: 510(k) Registry: GUDID Class:II

  • CoolGlide Excel

    Listed Registry: GUDID Class:II

  • truSculpt 25

    Listed Registry: GUDID Class:II

  • truSculpt 16

    Listed Registry: GUDID Class:II

  • Pearl Fractional Standoffs

    Active Regimes: 510(k) Registry: GUDID Class:II

  • Solera Titan

    Active Regimes: 510(k) Registry: GUDID Class:II

  • enlighten Low Energy Green

    Listed Registry: GUDID Class:II

  • Titan

    Active Regimes: 510(k) Registry: GUDID Class:II

  • AviClear Large handpiece

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:II

  • truSculpt 2 MHz

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:II

  • xeo

    Active Regimes: CE MDR CE MDD Registry: EUDAMEDGUDID Class:II

  • truSculpt 3D

    Listed Registry: GUDID Class:II

  • Titan S

    Listed Registry: GUDID Class:II

  • truSculpt 5 RF handpiece

    Listed Registry: GUDID Class:II

  • enlighten Standard

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:II

  • LP560

    Active Regimes: 510(k) Registry: GUDID Class:II

  • truSculpt

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:II

  • Genesis Plus

    Listed Registry: GUDID Class:II

  • CoolView

    Active Regimes: CE MDR 510(k) Registry: GUDID Class:II

  • Pearl

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • truSculpt 40

    Listed Registry: GUDID Class:II

  • OPS600

    Active Regimes: 510(k) Registry: GUDID Class:II

  • CoolGlide Vantage

    Listed Registry: GUDID Class:II

  • Genesis V

    Active Regimes: CE MDR 510(k) Registry: GUDID Class:II

  • CoolGlide Genesis

    Listed Registry: GUDID Class:II

  • truSculpt 2 RF handpiece

    Listed Registry: GUDID Class:II

  • Pearl Fractional

    Active Regimes: CE MDD 510(k) Registry: GUDID Class:II

  • Genesis Plus 1 mm Spot Size Adapter

    Listed Registry: GUDID Class:II

  • truSculpt 16 Ref 7001922

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIb

  • CoolView

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • enlighten Micro Lens Array (MLA) Ref 7001630

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • AviClear Laser System Ref K213461

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • enlighten III Laser System Ref K182997

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cutera Picosecond Laser System Ref K133945

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cutera enlighten III Laser System Ref K172077

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • truSculpt RF Device; truSculpt; truSculpt 3D Ref K180709

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Modification To Cutera Er:ysgg Laser Handpiece Ref K080530

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cutera Er:ysgg Laser Handpiece Ref K063867

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Family of CoolGlide Aesthetic Lasers Ref K153671

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cutera Tabletop Aesthetic Product Ref K042165

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • AviClear Laser System Ref K230660

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cutera Optional Pulsed Light Hand Piece Family Ref K050047

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cutera enlighten III Laser System Ref K160488

    Active Regimes: CE MDR CE MDD 510(k) Registry: 510(k) Class:II

Rows 1-50 of 85

Showing 1-50 of 85

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000010456
FDA FEI number
3002900199
DUNS number
041071643
EUDAMED status
Active
EUDAMED registered name
Cutera, Inc.
Registered address
3240, Bayshore Blvd, 94005, Brisbane, United States
Phone
+1 415-657-5500
PRRC contact
Julia Brown(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 12 Jan 2030

EUDAMED certificates (1)

TUV NORD Polska Sp. z o.o 2274 1 certificate

  • TNP/MDR/0029/5488/2025 Active

    Quality management system EU MDR

    Issued
    13 Jan 2025
    Expires
    12 Jan 2030

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 2 recalls initiated by CUTERA, INC., the earliest on 2010-05-08 and the most recent on 2013-10-16. By recorded status: 2 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2013

    • 16 Oct 2013 Z-0427-2014 Class II Terminated 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 and blisters consistent with partial thickness thermal burns to the skin. Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Canada Submission number: K122389

  • 2010

    • 8 May 2010 Z-0329-2011 Unclassified (pre-2012) Terminated Risk of burns-- under certain conditions, devices containing a gold plated end block could produce energy above what is stated on the device setting. Distribution: Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD,…
      Full distribution text Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OK, OR, PA, OH, SC, TN, TX, UT, VA, VT, WA, WI, WV, AND WY and the countries of Argentina, Australia, Austria, Barbados, Belgium, Bermuda, Brazil, Bulgaria, Canada, Chile, China, Columbia, Croatia, Cypress, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Lle de la Reunion, Mexico, New Zealand, Phillipines, Poland, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey, UAE, and Ukraine.
      Submission number: K042165

Frequently asked questions

How many devices does CUTERA, INC. have in the registry?

The registry currently lists 85 devices for CUTERA, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list CUTERA, INC.'s devices?

Among its 50 most recently registered devices, CUTERA, INC. has devices listed in EUDAMED (12 devices), FDA 510(k) (12 devices) and FDA GUDID (38 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do CUTERA, INC.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for CUTERA, INC.'s devices are Class IIb and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for CUTERA, INC.?

FDA recall records list 2 recalls initiated by CUTERA, INC., the most recent initiated on 16 Oct 2013. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for CUTERA, INC.?

EUDAMED lists 1 certificate for CUTERA, INC. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 13 Jan 2025.

What are the newest devices from CUTERA, INC. in the registry?

The most recently registered devices listed for CUTERA, INC. include truSculpt iD, Titan V, CoolView and AviClear.

Generated automatically from registry data and not verified by a human reviewer.