Glo Mask TN2332
Glo Mask TN2332 is a Class II device made by iSMART Developments, Ltd., cleared under FDA 510(k) K191629 on 12 Sep 2019 and listed in FDA GUDID since 27 Jan 2025 (UDI-DI 05060534510944), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05060534510944 | Date27 Jan 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK191629 | Date12 Sep 2019 | StatusActive |
Official records
- AccessGUDID record 05060534510944
- FDA 510(k) database K191629
Across registries
- FDA 510(k) K191629 decided 12 Sep 2019 Active
- FDA GUDID UDI-DI 05060534510944 listed 27 Jan 2025 Listed
Timeline
- Cleared FDA 510(k) K191629
- Listed FDA GUDID 05060534510944
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Glo Mask
- Generic name
- Cosmetic red-light phototherapy system, home-use
- Model / reference
- TN2332
- Primary DI / UDI-DI
- 05060534510944
- 510(k) Number
- FDA product code
- OHS
- GMDN term
- Cosmetic red-light phototherapy system, home-use
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code OHS (Light Based Over The Counter Wrinkle Reduction).
- LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) by Sunglor Technology Co., Ltd.
- Radiant Renewal Skincare Wand (HD-44, HD-44A, HD-44B, HD-44C, HD-69, HD-69A, HD-69B) by Shenzhen Nuon Medical Equipment Co., Ltd.
- LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073) by Shenzhen Rainbow Technology Co., Ltd.
- SILK'N FX by Home Skinovations, Ltd.
- RED Light Device by zhongshan Bisen plastic electronic products CO, LTD
- MEGELIN LED Light Therapy Mask (JML1, JML1+JML2); MEGELIN LED Light Therapy Mask (JML3, JML3+JML4); MEGELIN LED Light Therapy Mask (JML5, JML5+JML7); MEGELIN LED Light Therapy Mask (JML6, JML6+JML8); MEGELIN LED Light Therapy Mask (JML9, JML9+JML10) by Shenzhen Zhenxing Ruitong Technology Co., Ltd.
- Led Mask Platinum Md by Cellreturn Co., Ltd.
- LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) by Light Tree Ventures Europe B.V.
- Skin Care Beauty Mask (Model: MJ-06) by Shenzhen Kaiyan Medical CO, Ltd.
- myLEDmask 2 (MJ-144) by Light Tree Ventures Europe B.V.