Ophthalmic Trichiasis Probe
FDA 510(k) K923629 · Mira, Inc.
510(k) numberK923629
Submission
- Device name
- Ophthalmic Trichiasis Probe
- Applicant
- Mira, Inc.
Waltham, MA, US - Received
- July 21, 1992
- Decision date
- October 19, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HPS – Unit, Cryophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4170
- Specialty
- Ophthalmic
Other 510(k)s with product code HPS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K202038 | CryoTreQHPS · Traditional | VitreQ BV | 12/30/2020SE |
| K940373 | Ophthalmic Cryo UnitHPS · Traditional | Dutch Ophthalmic USA, Inc. | 07/18/1994SE |
| K903303 | Spembly Medical 242 Cryounit/Series 242 CryoprobesHPS · Traditional | Spembly Medical , Ltd. | 10/11/1990SE |
| K874555 | Keeler Acu 22XT Ophthalmic Cryo UnitHPS · Traditional | Keeler Instruments, Inc. | 01/29/1988SE |
| K873388 | Keeler Ctu Cryo SystemHPS · Traditional | Keeler Instruments, Inc. | 11/13/1987SE |
| K870195 | United Surgical Corp. Cryoptic PlusHPS · Traditional | United Surgical Corp. | 02/20/1987SE |
| K833747 | Gallie CryonucleatorHPS · Traditional | Mono Research Laboratories | 05/09/1984SE |
| K801418 | Keeler Amoils Acull Cryo Ophthalmic UnitHPS · Traditional | Keeler Optical Products , Ltd. | 07/21/1980SE |
| K790102 | Model 556-01 CryoextractorHPS · Traditional | Intermedics, Inc. | 02/12/1979SE |
| K781338 | Beaver Cataract CyroxtractorHPS · Traditional | Edward Weck, Inc. | 02/12/1979SE |
More from Edward Weck, Inc.
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| K950806 | Solid Dilicone Implants, Sdilicone Sponge ImplantsHQX · Traditional | 06/05/1996SE |
| K941495 | Return Path Diathermy HandleHQR · Traditional | 07/15/1994SE |
| K933527 | Modification of Anterior Segment ElectrodesHWA · Traditional | 01/25/1994SE |
| K894248 | Converter SystemHQE · Traditional | 02/27/1990SE |
| K891601 | Power Operated and Controlled Vitreous ScissorsHQE · Traditional | 05/23/1989SE |
| K890448 | Light Source, Endoscop, Xenon ArcFFS · Traditional | 05/08/1989SE |
| K863246 | MiraliteHQF · Traditional | 10/31/1986SE |
| K863591 | Endophotocoagulation ProbeHQF · Traditional | 10/10/1986SE |
| K855105 | Simmons ShellHQT · Traditional | 03/31/1986SE |
Questions and answers
When was Ophthalmic Trichiasis Probe cleared by the FDA?
Ophthalmic Trichiasis Probe (K923629) received a 510(k) decision of Substantially Equivalent on October 19, 1992, 90 days after the submission was received.
What is the product code of K923629?
The FDA product code is HPS – Unit, Cryophthalmic, a Class II (moderate risk) device regulated under 21 CFR 886.4170.