Emerge
Emerge Laser Assembly
12manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Beijing (7), Jiangsu (2), Hebei (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Beijing Beautemax Technology Limited | Beijing | Beijing | Contract manufacturer | 13 |
| Beijing Spiritlaser Science & Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 21 |
| Beijing Winkonlaser Technology Limited | Beijing | Beijing | Contract manufacturer | 14 |
| Beijing Perfectlaser Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 12 |
| Sanhe Jumei Technology Co., Ltd. | Sanhe | Hebei | Manufacturer | 12 |
| Beijing SEA Heart International Science AND Technology Co., Ltd. | Beijing | Beijing | Exporter | 7 |
| Shanghai Apolo Medical Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 5 |
| Beijing Sincoheren Science & Technology Development Co., Ltd. | Bejing | Beijing | Repacker / relabeller | 5 |
| Weifang Mingliang Electronics Co., Ltd. | Weifang | Shandong | Manufacturer | 2 |
| Wingderm Electro-Optics Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Olemy Laser Technology Ltd | Wuxi | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Cynosure, LLC, United States |
|---|---|
| FDA product code | ONG |
| Device type | Powered Laser Surgical Instrument With MicrobeamFractional Output |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K111840 |
| Record published | 2016-09-24 |
| Record revised | 2023-06-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0500-0001 | In distribution | |
| 0500-0001R | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| eCO2 3D | Cynosure Lutronic Technology Corporation | 18 |
| Clear & Brilliant | Solta Medical, Inc. | 8 |
| Clear+brilliant Touch | Solta Medical, Inc. | 7 |
| Edge Guide Tip | Jeisys Medical Inc. | 5 |
| Edge Handpiece | Jeisys Medical Inc. | 3 |
| Apolomed | Shanghai Apolo Medical Technology Co., Ltd. | 3 |
| Miria | Avava, Inc. | 2 |
| Max R Handpiece | Cynosure, LLC | 2 |
| Smooth Beauty Laser | Tria Laser Inc | 2 |
| 1064+ Handpiece | Cynosure, LLC | 2 |
| Stellar™ M22 | Lumenis, Ltd. | 2 |
| Emerge Handpiece | Cynosure, LLC | 2 |
Showing 12 of 59. All products under Powered Laser Surgical Instrument With MicrobeamFractional Output
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.