| Primary Device ID | 00858027006495 |
| NIH Device Record Key | be4523a8-c84c-41c2-88d4-0804ccc1f8b2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TearCare System - TearCare SmartLids |
| Version Model Number | FG 07938 |
| Catalog Number | 5-117 |
| Company DUNS | 962750381 |
| Company Name | SIGHT SCIENCES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858027006495 [Primary] |
| ORZ | Eyelid Thermal Pulsation System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-11 |
| Device Publish Date | 2022-03-03 |
| 00858027006549 - TearCare MGX System - TearCare MGX Technology Kit | 2025-05-08 TearCare MGX System - TearCare MGX Technology Kit including SmartHub, SmartHub Nest, and SmartCable |
| 00858027006297 - TearCare MGX System - TearCare MGX SmartLids | 2025-05-07 TearCare MGX System - TearCare MGX SmartLids |
| 00858027006594 - OMNI Edge Surgical System | 2025-03-14 OMNI Edge Surgical System |
| 00858027006433 - OMNI Surgical System | 2023-10-25 OMNI Surgical System, 21 uL |
| 00858027006389 - TearCare(R) Clearance Assistant PLUS | 2023-08-30 TearCare Clearance Assistant PLUS |
| 00858027006280 - TearCare SmartLid | 2023-08-22 Eyelid heat therapy system applicator |
| 00858027006266 - TearCare(R) Clearance Assistant - Sterile | 2023-08-04 Forceps - Sterile |
| 00858027006525 - OMNI Surgical System | 2022-08-30 OMNI Surgical System: Ergo series of revisions |