Lucea LED®
LCA 100 Mobile B
1manufacturer
4catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Kaiyan Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
Record
| Listed by | Maquet Gmbh, Germany |
|---|---|
| FDA product code | FSS |
| Device type | Light, Surgical, Floor Standing |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4580 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K113679 |
| Record published | 2016-09-15 |
| Record revised | 2024-11-18 (version 8) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Handling environment atmospheric pressure 50 to 106 KiloPascal; Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment humidity 20 to 75 % RH; Storage environment humidity 20 to 75 % RH; Handling environment temperature -10 to 60 °C; Storage environment temperature -10 to 60 °C |
| Distribution end date | 2024-10-14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ARDLCA309005A | Withdrawn | |
| ARDLCA309004A | Withdrawn | |
| ARDLCA309006A | Withdrawn | |
| ARDLCA309007A | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Maquet Rolite | Maquet Gmbh | 35 |
| StarTrol | Huot Instruments, LLC | 9 |
| HarmonyAIR | Steris Corporation | 6 |
| Aesculap | Aesculap AG | 5 |
| Amtai | Amtai Medical Equipment, Inc. | 4 |
| Nico Myriad-LX | Nico Corporation | 3 |
| Sunoptic Technologies | Sunoptic Technologies, LLC | 3 |
| Aurora Surgical Light Series | Skytron, LLC | 2 |
| Maxx Luxx LED 160 | Avante | 2 |
| MS Sim.LED OpL wDB | S.i.m.e.o.n. Medical GMBH & Co.KG | 2 |
| STARLED3 NX | Acem SPA | 2 |
| Nico Myriad-LX | Sunoptic Technologies, LLC | 2 |
Showing 12 of 37. All products under Light, Surgical, Floor Standing
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.