# Cutera, Inc. (manufacturer, Brisbane, CA): 2 new FDA device listings, incl. powered laser surgical instrument

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Cutera, Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Brisbane, CA, US |
| New listings | 2 |
| Devices | Powered Laser Surgical Instrument; Electrosurgical, Cutting & Coagulation & Accessories |
| Product codes | GEX, GEI |
| Device classes | Class II |
| Medical specialties | General, Plastic Surgery |
| Brand names | AviClear; truSculpt, truSculpt iD, truSculpt 40, truSculpt 16 |
| First new listing | 2026-09-25 |
| Latest new listing | 2026-09-25 |
| FDA registration number | 2954354 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.