Identity
- Trade Name
- Glo Mask FDA UDI
- Generic Name
- Cosmetic red-light phototherapy system, home-use FDA UDI
- Device Name
- Glo Mask Rebrand of Luma Pro Facemask (TN2332)- Indicated for Wrinkles. FDA UDI
- Model / Reference
- TN2332 FDA UDI
- Description
- Glo Mask Rebrand of Luma Pro Facemask (TN2332)- Indicated for Wrinkles. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060534510944 FDA UDI
- 510(k) Number
- K191629 FDA UDI
- FDA Product Code
- OHS FDA UDI
- GMDN Term
- Cosmetic red-light phototherapy system, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cosmetic red-light phototherapy system, home-use
Glo Mask by iSMART Developments, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K191629 also covers:
- Beauty Pie C-Wave Light Facial Mask — iSMART Developments, Ltd.
- Boost LED Face Mask — iSMART Developments, Ltd.
- Deesse Pro Express — iSMART Developments, Ltd.
- Dp DERMACEUTICALS L.E.D.+ FACE — iSMART Developments, Ltd.
- Dp Dermaceuticals L.E.D. FACE — iSMART Developments, Ltd.
- Kandyway Eternal Glow MD - Face — iSMART Developments, Ltd.
- Light therapy LED facemask from City Beauty — iSMART Developments, Ltd.
- North American Kandyway Eternal Glow MD-Face — iSMART Developments, Ltd.
- Omnilux Contour FACE — iSMART Developments, Ltd.
- Priori UnveiLED — iSMART Developments, Ltd.
- QMS Derma Expert Facemask — iSMART Developments, Ltd.
- SMOOTHSKIN DuoLux LED Facemask — iSMART Developments, Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- iSMART Developments, Ltd.
Sources (1)
- FDA UDI 6ec85e5b-056e-4eab-b82c-1b0156badfcd 35 fields · synced May 31, 2026