FDA product code ORZ: Eyelid Thermal Pulsation System
ORZ is the FDA product code for eyelid thermal pulsation system. It is a Class II device, regulated under 21 CFR 886.5200 and reviewed by the Ophthalmic panel. FDA has cleared 12 510(k) submissions under ORZ, 5 in the last five years, from 4 different applicants. The average 510(k) review took 141 days (median 105); 205 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 3 recalls for ORZ devices, 1 initiated in the last five years.
Definition
Therapeutic application of heat and massage to the eyelids.
Classification
| Field | Value |
|---|---|
| Device name | Eyelid Thermal Pulsation System |
| Device class | Class II |
| Regulation | 21 CFR 886.5200 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
510(k) clearances per year for ORZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 116 |
| 2019 | 1 | 29 |
| 2020 | 1 | 93 |
| 2021 | 1 | 90 |
| 2023 | 1 | 254 |
| 2024 | 1 | 256 |
| 2025 | 1 | 211 |
| 2026 | 2 | 149 |
Compare with all 510(k) review times · Search every ORZ clearance
Top ORZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Sight Sciences, Inc. | 5 | 2026-08-18 |
| Tearscience, Inc. | 4 | 2019-10-22 |
| Tear Film Innovations, Inc. | 2 | 2020-05-21 |
| Novoxel , Ltd. | 1 | 2024-11-04 |
Most recent ORZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K262479 | Sight Sciences, Inc. | TearCare System | 2026-08-18 | 29 |
| K252409 | Sight Sciences, Inc. | TearCare MGX System | 2026-04-27 | 269 |
| K242786 | Sight Sciences, Inc. | TearCare MGX System | 2025-04-15 | 211 |
| K240512 | Novoxel , Ltd. | Tixel i (TXLI0001) | 2024-11-04 | 256 |
| K231084 | Sight Sciences, Inc. | TearCare MGX System | 2023-12-27 | 254 |
Recalls for ORZ devices
3 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-03-23.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code ORZ?
ORZ is the FDA product code for eyelid thermal pulsation system. It is a Class II device, regulated under 21 CFR 886.5200 and reviewed by the Ophthalmic panel.
What device class is ORZ?
Class II, regulation 21 CFR 886.5200. Typical premarket route: 510(k).
How long does a 510(k) take for product code ORZ?
Across 12 cleared submissions the average was 141 days from receipt to decision (median 105).
Which companies have the most ORZ clearances?
Sight Sciences, Inc. (5); Tearscience, Inc. (4); Tear Film Innovations, Inc. (2); Novoxel , Ltd. (1).
Have ORZ devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2022-03-23.
Next steps
- Run an FDA pathway report with predicate devices for product code ORZ
- Run a recall and safety report across every ORZ manufacturer
- Watch product code ORZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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