| Primary Device ID | 00858027006211 |
| NIH Device Record Key | 260e9fac-70bf-447f-919c-6de131406e1b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TearCare System |
| Version Model Number | FG 05031 |
| Company DUNS | 962750381 |
| Company Name | SIGHT SCIENCES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| 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 | 00858027006211 [Primary] |
| IRT | Pad, Heating, Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-02-01 |
| 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 |
| 00858027006501 - Sion Surgical Instrument | 2022-08-09 The Sight Sciences SION™ Surgical Instrument is a handheld, single use, sterile, bladeless surgical instrument. |
| 00858027006457 - TearCare System - TearCare SmartHub Kit | 2022-03-11 TearCare System SmartHub Kit including SmartHub, charging nest, and charging adapter |
| 00858027006495 - TearCare System - TearCare SmartLids | 2022-03-11 Eyelid heat therapy system applicator |