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Sign in to claim this brandCUTERA, INC.
United States·US-MF-000010456
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 3240, Bayshore Blvd, Brisbane, United States
- Website
- www.cutera.com
- —
- —
- [email protected]
- Phone
- +1 415-657-5500
- PRRC Contact
- Philipp Novales-Li
- EUDAMED SRN
- US-MF-000010456
- FDA FEI Number
- 3002900199
- DUNS Number
- 041071643
Catalogue (85)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| truSculpt iD | truSculpt iD | FDA UDI | Class II | Active |
| Titan V | Titan V | FDA UDI | Class II | Active |
| CoolView | CoolView | FDA UDI | Class II | Active |
| AviClear | AviClear | FDA UDI | Class II | Active |
| Solera Opus | Solera Opus | FDA UDI | Class II | Active |
| excel V | excel V | FDA UDI | Class II | Active |
| CoolGlide CV | CoolGlide CV | FDA UDI | Class II | Active |
| ProWave 770 | ProWave 770 | FDA UDI | Class II | Active |
| CoolGlide Excel | CoolGlide Excel | FDA UDI | Class II | Active |
| truSculpt 25 | truSculpt 25 | FDA UDI | Class II | Active |
| truSculpt 16 | truSculpt 16 | FDA UDI | Class II | Active |
| Pearl Fractional Standoffs | Pearl Fractional Standoffs | FDA UDI | Class II | Active |
| Solera Titan | Solera Titan | FDA UDI | Class II | Active |
| enlighten | enlighten Low Energy Green | FDA UDI | Class II | Active |
| Titan | Titan | FDA UDI | Class II | Active |
| AviClear | AviClear Large handpiece | FDA UDI | Class II | Active |
| truSculpt | truSculpt 2 MHz | FDA UDI | Class II | Active |
| xeo | xeo | FDA UDI | Class II | Active |
| truSculpt 3D | truSculpt 3D | FDA UDI | Class II | Active |
| Titan S | Titan S | FDA UDI | Class II | Active |
| truSculpt 5 RF handpiece | truSculpt 5 RF handpiece | FDA UDI | Class II | Active |
| enlighten | enlighten Standard | FDA UDI | Class II | Active |
| Lp560 | LP560 | FDA UDI | Class II | Active |
| truSculpt | truSculpt | FDA UDI | Class II | Unknown |
| Genesis Plus | Genesis Plus | FDA UDI | Class II | Active |
| CoolView | CoolView | FDA UDI | Class II | Active |
| Pearl | Pearl | FDA UDI | Class II | Active |
| truSculpt 40 | truSculpt 40 | FDA UDI | Class II | Active |
| Ops600 | OPS600 | FDA UDI | Class II | Active |
| CoolGlide Vantage | CoolGlide Vantage | FDA UDI | Class II | Active |
| Genesis V | Genesis V | FDA UDI | Class II | Active |
| CoolGlide Genesis | CoolGlide Genesis | FDA UDI | Class II | Active |
| truSculpt 2 RF handpiece | truSculpt 2 RF handpiece | FDA UDI | Class II | Active |
| Pearl Fractional | Pearl Fractional | FDA UDI | Class II | Active |
| Genesis Plus 1 mm Spot Size Adapter | Genesis Plus 1 mm Spot Size Adapter | FDA UDI | Class II | Active |
| truSculpt 16 | 7001922 | EUDAMEDFDA UDI | Class IIb | Active |
| CoolView | 7002209, 7002058T, 7002591, 7002589T | EUDAMEDFDA UDI | Class IIb | Active |
| enlighten Micro Lens Array (MLA) | 7001630 | EUDAMEDFDA UDI | Class IIb | Active |
| AviClear Laser System | K213461 | FDA 510(k) | Class II | Active |
| enlighten III Laser System | K182997 | FDA 510(k) | Class II | Active |
| Cutera Picosecond Laser System | K133945 | FDA 510(k) | Class II | Active |
| Cutera enlighten III Laser System | K172077 | FDA 510(k) | Class II | Active |
| truSculpt RF Device; truSculpt; truSculpt 3D | K180709 | FDA 510(k) | Class II | Active |
| Modification To Cutera Er:ysgg Laser Handpiece | K080530 | FDA 510(k) | Class II | Active |
| Cutera Er:ysgg Laser Handpiece | K063867 | FDA 510(k) | Class II | Active |
| Family of CoolGlide Aesthetic Lasers | K153671 | FDA 510(k) | Class II | Active |
| Cutera Tabletop Aesthetic Product | K042165 | FDA 510(k) | Class II | Active |
| AviClear Laser System | K230660 | FDA 510(k) | Class II | Active |
| Cutera Optional Pulsed Light Hand Piece Family | K050047 | FDA 510(k) | Class II | Active |
| Cutera enlighten III Laser System | K160488 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
- MDSS GmbH DE
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 16, 2013 | Z-0427-2014 | — | 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. |
| May 8, 2010 | Z-0329-2011 | — | 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. |