FDA UDI
In Commercial Distribution
🇺🇸 United States
TearCare MGX System - TearCare MGX SmartLids
DI: 00858027006297
·
Model: FG 08785
·
Sight Sciences, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TearCare MGX System - TearCare MGX SmartLids
- Primary DI
- 00858027006297
- Version / Model
- FG 08785
- Catalog Number
- 5-109
- Company Name
- Sight Sciences, Inc.
- Labeler DUNS
- 962750381
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-29
- Public Version
- 1
- Public Version Date
- 2025-05-07
- Public Version Status
- New
- Public Device Record Key
- 9a1c3c88-2c4c-49c6-bd08-45656f7bfb68
Device Description
TearCare MGX System - TearCare MGX SmartLids
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ORZ | Eyelid Thermal Pulsation System | Ophthalmic | 886.5200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62516 | Eyelid heat therapy system applicator | A skin-adherent device intended to be connected to a system control unit to deliver localized heat therapy to the outer eyelid surfaces of an adult patient during treatment of meibomian gland dysfunction (MGD), dry eye syndromes, blepharitis (inflammation of the eyelid), and other related ocular conditions. It consists of an adhesive heat patch/strip that is adhered to the eyelid(s), and typically a cable to allow connection to the control unit. It is intended to be used by a professional in a professional (e.g., clinical) setting. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00858027006297 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K242786 | 000 |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 107 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 55 Degrees Celsius