Sun Nuclear Micro+
The MICRO MLG 200 lasers are intended to be used for aligning patients to medical diagnostic imaging and radiation therapy equipment which utilizes ionizing radiation. The micro lasers are…
The MICRO MLG 200 lasers are intended to be used for aligning patients to medical diagnostic imaging and radiation therapy equipment which utilizes ionizing radiation. The micro lasers are intended to be used in medical clinic or hospital settings by trained medical staff. The lasers are not designed to be used around flammable anesthetics, which might present a risk of explosion or fire. The lasers are not intended to be used in a sterile or corrosive environment. No other uses are intended or implied.
Who Else Makes It
Concentrated in Shandong (2), Guangdong (2), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Guangdong Meicen Medical Equipment Co., Ltd. | Foshan | Guangdong | Manufacturer | 7 |
| Shenzhen Tengfei YU Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Sun Nuclear Corporation, United States |
|---|---|
| FDA product code | IWE |
| Device type | Monitor, Patient Position, Light-Beam |
| Device class | Class 1 |
| Regulation | 21 CFR 892.5780 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-01-25 |
| Record revised | 2023-01-09 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MLR+350 | In distribution | |
| MLG 200 | In distribution | |
| MLB 150 | In distribution | |
| MLG 150 | In distribution | |
| MLG+300 | In distribution | |
| MLB+300 | In distribution | |
| MLR 150 | In distribution | |
| MLB+350 | In distribution | |
| MLR 200 | In distribution | |
| MLB 200 | In distribution | |
| MLR+300 | In distribution | |
| MLG+350 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Meicen | Guangdong Meicen Medical Equipment Co., Ltd. | 58 |
| Centralite Patient Positioning Laser | Diacor, Inc. | 23 |
| Dorado | L A P Gmbh Laser Applikationen | 20 |
| Hercules | Aadco Medical, Inc. | 18 |
| CT Sim+ | Sun Nuclear Corporation | 18 |
| Aadco | Aadco Medical, Inc. | 14 |
| HIT Laser | C-RAD Positioning AB | 13 |
| MRI-Safe | Aadco Medical, Inc. | 11 |
| Carina | L A P Gmbh Laser Applikationen | 10 |
| Apollo | L A P Gmbh Laser Applikationen | 10 |
| Sun Nuclear Micro+ MR | Sun Nuclear Corporation | 6 |
| Huestis Centralite Patient Positioning Laser | Huestis Machine Corp. | 6 |
Showing 12 of 26. All products under Monitor, Patient Position, Light-Beam
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.