Organization (Industry)
Cutera, Inc.
ClinicalTrials.gov lists Cutera, Inc. as lead sponsor of 42 trials. It has 1 active development program.
Search trials, drugs, companies and investigators, and follow each one to the others. Individual plan, $249/seat/mo. Card required.
Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.
2026 is partial: 1 registered with a 2026 start date. The dashed outline is the pace from the 1 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 0.6 trial starts a year over the five years to September, under the 5 a year the method needs.
This page covers Cutera, Inc.: 42 lead-sponsored trials and 2 legal-entity registrations.
Disease areas (17)
Shown in this order: most trials first.
| Disease area | Trials |
|---|---|
| Cicatrix | 5 |
| Fibrosis | 5 |
| Acne Vulgaris | 4 |
| Hyperpigmentation | 3 |
| Telangiectasis | 3 |
Showing 5 of 17 disease areas.
Trials by start year as sponsor or collaborator (13)
Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.
Show the table of trials by start year as sponsor or collaborator
| Year | Trials started |
|---|---|
| 2026 (partial year) | 1 |
| 2022 | 2 |
| 2020 | 1 |
| 2018 | 3 |
| 2017 | 8 |
| 2016 | 11 |
| 2015 | 5 |
| 2014 | 2 |
| 2013 | 6 |
| 2012 | 1 |
Showing 10 of 13 years.
Recruitment duration, a model prediction: 1 trial still running at the 2026-10-09 snapshot, fewer than the 5 needed for a median. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
Active development programs (1)
| Drug | Disease area | Max phase | Trials |
|---|---|---|---|
| Other | Hypertrophy | Not reported | 1 |
Sponsor delivery record (1)
Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.
| Enrollment | Timeline |
|---|---|
| 10% hit target (n=10) | 93% on time (n=14) |
Journals published in (1)
| Journal | Publications |
|---|---|
| Lasers in surgery and medicine | 2 |
US granted patents (1)
Patents are not classified by disease area in the source, so this is the organization's overall portfolio, not a split by disease.
| US patents granted | Granted in the last 5 years | Most recent grant |
|---|---|---|
| 48 | 11 | 2025-07-15 |
FDA warning letters (1)
| Issue date | Letter |
|---|---|
| 2023-02-08 | cutera-inc-639552-02082023 |
FDA inspection record (1)
| Latest classification | Inspections |
|---|---|
| NAI | 5 |
FDA recalls (1)
| Product | Classification | Initiated |
|---|---|---|
| Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distributed by Cutera, Inc., Brisbane, CA The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite. The truSculpt infrared (optional) and RF energies are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. | Class II | 2013-10-16 |
FDA import refusals (1)
| Refused import lines | Latest refusal |
|---|---|
| 1 | 2018-08-31 |
Manufacturing and distribution sites (1)
| Facility | Location | Regulators | Member organization |
|---|---|---|---|
| CUTERA, INC. | BRISBANE, US | FDA |
Latest dated events (101)
Shown in this order: newest first.
| Date | Event | Source |
|---|---|---|
| 2026-04-28 | Trial started | Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI)) |
| 2025-07-15 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2025-03-25 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2025-02-18 | Patent granted | Granted US patents (PatentsView / USPTO) |
| 2024-10-22 | Patent granted | Granted US patents (PatentsView / USPTO) |
Showing 5 of 101 events.
Biomarker capability evidence (12)
Shown in this order: tier desc, then gene symbol.
| Gene | Role | Evidence |
|---|---|---|
| ASNS | Trial sponsor | Named in trial inclusion criteria |
| SMNDC1 | Trial sponsor | Named in trial inclusion criteria |
| SMNDC1 | Trial sponsor | Named in trial inclusion criteria |
| SMNDC1 | Trial sponsor | Named in trial inclusion criteria |
| PHLDA2 | Trial sponsor | Named in trial exclusion criteria |
Showing 5 of 12 evidence rows.
Not on this page
Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, approved assets, sec-reported annual financials, financing and grant events, fda untitled letters, climate targets, as filed, workforce and board diversity, as filed, organization relationships, clia clinical laboratory certificates, and biomarkers this organization publishes on.