# Venus Concept Inc. (manufacturer, San Jose, CA): 7 new FDA device listings, incl. powered light based non-laser surgical instrument with thermal effect

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Venus Concept Inc. |
| Role | Manufacturer |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility; Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device |
| Location | San Jose, CA, US |
| New listings | 7 |
| Devices | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect; Massager, Vacuum, Radio Frequency Induced Heat; Electrosurgical, Cutting & Coagulation & Accessories; Powered Laser Surgical Instrument |
| Product codes | ONF, PBX, GEI, GEX |
| Device classes | Class II |
| Medical specialties | General, Plastic Surgery |
| Brand names | Venus Versa; Venus Heal; Venus Legacy BX; Venus Viva; Venus Epileve; Venus Viva SR; Venus Freeze (MP)2 |
| First new listing | 2026-07-06 |
| Latest new listing | 2026-07-06 |
| FDA registration number | 3006515340 |
| 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.
- Several new listings at once.
- U.S. establishment.

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: 2026-10-28T20:51:27.468Z.
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.