Data / Medical devices / United States / Emerge Technologies, Inc.
Emerge Technologies, Inc.: FDA-registered device maker in Coppell, TX, United States, 4 510(k) clearances
Emerge Technologies, Inc. is registered with the FDA (registration 3016750352) in Coppell, TX, United States. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated June 9, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016750352
- Address
- 955 Freeport Pkwy #100, Coppell, TX, United States, 75019
- Owner or operator
- Emerge Technologies (10070335)
- Roles
- Complaint file establishment, Repackager or relabeler
- First device listed
- May 21, 2025
- Registered through
- 2026
- Brand names listed
- Rotating Sonic Cleansing Brush, re-nu Smart Beauty 360 Lift & Sculpt (RENUMFLME), re-nu Smart Beauty IPL (RENUHRIPE), re-nu Smart Beauty Laser Therapy Hair Comb, re-nu Smart Beauty Red Light Laser Hair Brush, re-nu Smart Beauty Silicone LED Mask, re-nu Smart Beauty Wrinkle Treatment Mask (RENUJOVS4D)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Dermabrasion, Powered | GFE | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Laser, Comb, Hair | OAP | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Light Based Over-The-Counter Hair Removal | OHT | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | 2 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 9, 2025 | K250830 | LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK) | OHS | Substantially Equivalent | Shenzhen Sungrow Led Technology Co., Ltd. | accessdata.fda.gov |
| April 5, 2024 | K240360 | Wrinkle Treatment Device (JM2) | OHS | Substantially Equivalent | Shenzhen Qianyu Technology Co., Ltd. | accessdata.fda.gov |
| November 20, 2023 | K232575 | Hair Removal Device, Model(s): R2815-G Pro, R2815-G | OHT | Substantially Equivalent | Shenzhen Jianchao Intelligent Technology Co., Ltd. | accessdata.fda.gov |
| May 26, 2022 | K213027 | Laser Hair Growth Comb | OAP | Substantially Equivalent | Kam Yuen Plastic Products , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Laser, Comb, Hair
- All makers of Light Based Over The Counter Wrinkle Reduction
- All makers of Brush, Dermabrasion, Powered
- All makers of Over-The-Counter Powered Light Based Laser For Acne
- All makers of Light Based Over-The-Counter Hair Removal
Updated June 9, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.