Definition: Therapeutic Application Of Heat And Massage To The Eyelids.
| Device Type ID | 4400 |
| Device Name | Eyelid Thermal Pulsation System |
| Physical State | Comprised Of Two Components, A Single-use Disposable Unit Made Of Biocompatible Polycarbonate And Silicone That Is Inserted Around The Patient's Eyelids, And A Handheld Control System, Which Connects To The Single-use Disposable Unit |
| Technical Method | Battery-operated, Handheld Device That The Physician Uses In An In-office Procedure To Control The Application Of Warmth And Massage To The Eyelids. The Handheld Device Connects To A Single-use Disposable Unit Made Of Biocompatible Polycarbonate And |
| Target Area | Eyelids |
| Regulation Description | Eyelid Thermal Pulsation System. |
| Regulation Medical Specialty | Ophthalmic |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Contact Lenses And Retinal Devices Branch (CLRD) |
| Submission Type | 510(k) |
| CFR Regulation Number | 886.5200 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ORZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4400 |
| Device | Eyelid Thermal Pulsation System |
| Product Code | ORZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Eyelid Thermal Pulsation System. |
| CFR Regulation Number | 886.5200 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
TEAR FILM INNOVATIONS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TEARSCIENCE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 4 |
| Total Device Problems | 4 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Tearscience, Inc | II | Mar-22-2017 |
| 2 | Tearscience, Inc | II | Oct-17-2016 |