Identity
- Trade Name
- OralID Fitted Glasses FDA UDI
- Generic Name
- Tinted non-prescription spectacles FDA UDI
- Device Name
- The OralID Fitted Glasses are designed as an accessory for use with the OralID device. These fitted glasses feature a filter that enhances the visualization capabilities of the OralID device, which is used for oral cancer screening. The filtered lenses are optimized to block specific wavelengths of light, enabling the observation of healthy and abnormal tissues when used in conjunction with the OralID device. These glasses are intended for use in dental and medical settings. FDA UDI
- Model / Reference
- OralID Fitted Glasses 1ct FDA UDI
- Description
- The OralID Fitted Glasses are designed as an accessory for use with the OralID device. These fitted glasses feature a filter that enhances the visualization capabilities of the OralID device, which is used for oral cancer screening. The filtered lenses are optimized to block specific wavelengths of light, enabling the observation of healthy and abnormal tissues when used in conjunction with the OralID device. These glasses are intended for use in dental and medical settings. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00370275123088 FDA UDI
- 510(k) Number
- K123169 FDA UDI
- FDA Product Code
- HQY FDA UDI
- GMDN Term
- Tinted non-prescription spectacles FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.5850 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
No
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tinted non-prescription spectacles
OralID Fitted Glasses by Forward Science Technologies Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K123169 also covers:
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 I | Pending data |
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Manufacturer
- Manufacturer
- Forward Science Technologies Llc
Sources (1)
- FDA UDI 1e7cb767-864f-457d-bce4-2310d0333a91 35 fields · synced May 30, 2026