FDA device listing
GentleMax Pro,GentleMax Pro, GentleLase Pro U, GentleYag Pro U,Gentle Pro Series
FDA device listing 1692739503 · Candela Corporation
Key facts
| Proprietary names | GentleMax Pro,GentleMax Pro, GentleLase Pro U, GentleYag Pro U,Gentle Pro Series |
|---|---|
| Owner/operator | Candela Corporation |
| Owner/operator number | 1218402 |
| Premarket submissions | K140122 |
| Product codes | GEX, PDZ |
| Device names | GEX - Powered Laser Surgical Instrument, PDZ - Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4810 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Candela Corporation |
| Establishment registrations | 3016496662 |
| FEI numbers | 3016496662 |
| Establishment operations | Complaint File Establishment, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database