FDA device listing
DOUBLE SURFACE PHOTO THERAPHY WITH TROLLY,GLANZA EXAMINATION MOBILE LIGHT,LED PHOTOTHERAPY LIGHT,OT LED 18 STAR MOBILE…
FDA device listing 1266066791 · BALAJI SURGICAL
Key facts
| Proprietary names | DOUBLE SURFACE PHOTO THERAPHY WITH TROLLY,GLANZA EXAMINATION MOBILE LIGHT,LED PHOTOTHERAPY LIGHT,OT LED 18 STAR MOBILE LIGHT,OT LED 5-STAR MOBILE LIGHT,OT LED 7 LED EXAMINATION LIGHT,OT LED ALEXA MOBILE LIGHT,OT LED APPLE -3 MOBILE LIGHT,OT LED APPLE- 4 MOBILE LIGHT,OT LED APPLE -5 MOBILE LIGHT,OT LED APPLE -6 MOBILE LIGHT,OT LED APPLE EXAMINATION LIGHT,OT LED BRIGHT -21 EXAMINATION LIGHT,OT LED… |
|---|---|
| Owner/operator | BALAJI SURGICAL |
| Owner/operator number | 10091836 |
| Product codes | FSS |
| Device names | FSS - Light, Surgical, Floor Standing |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4580 |
| Review panels | General & Plastic Surgery |
| Registered establishments | BALAJI SURGICAL |
| Establishment registrations | 3030558088 |
| FEI numbers | 3030558088 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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