# Aurora Dermo Corp (repackager or relabeler, Miami, FL): 9 new FDA device listings, incl. powered laser surgical instrument

**Score:** 65/100

| Field | Value |
|---|---|
| Establishment | Aurora Dermo Corp |
| Role | Repackager or relabeler |
| Establishment types | Repack or Relabel Medical Device |
| Location | Miami, FL, US |
| New listings | 9 |
| Devices | Powered Laser Surgical Instrument; Powered Light Based Non-Laser Surgical Instrument With Thermal Effect; Transducer, Ultrasonic, Diagnostic; System, Imaging, Pulsed Doppler, Ultrasonic; System, Imaging, Pulsed Echo, Ultrasonic |
| Product codes | GEX, ONF, ITX, IYN, IYO |
| Device classes | Class II |
| Medical specialties | General, Plastic Surgery, Radiology |
| Brand names | FRACTAL CO2 Laser; LUMINA; MATRIX 4D Hair Removal Laser; LEVAGE FUSION Surgical laser; PRISMA Q-SWITCH LASER; VISUALIS ULTRASOUND |
| First new listing | 2026-06-24 |
| Latest new listing | 2026-08-11 |
| FDA registration number | 3039935725 |
| Registration expires | 2026-12-31 |

## Why this score
- 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: 2026-11-04T21:52:36.524Z.
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.