Model SL-YZ5E
FDA 510(k) K962522 · Pacific Ophthalmic Supply
510(k) numberK962522
Submission
- Device name
- Model SL-YZ5E
- Applicant
- Pacific Ophthalmic Supply
Belmont, CA, US - Received
- June 14, 1996
- Decision date
- July 25, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HJO – Biomicroscope, Slit-Lamp, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1850
- Specialty
- Ophthalmic
Other 510(k)s with product code HJO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253834 | Visuref 600HJO · Traditional | Carl Zeiss Vision GmbH | 03/18/2026SE |
| K231760 | Hp-Oct (Hp-Oct)HJO · Traditional | Cylite Pty. , Ltd. | 03/08/2024SE |
| K222372 | Kowa SL-19HJO · Traditional | Kowa Company , Ltd. | 11/21/2022SE |
| K193188 | MiiS Horus Eye Anterior CameraHJO · Traditional | Medimaging Integrated Solution, Inc (Miis) | 01/14/2020SE |
| K182306 | Sunkingdom Slit LampHJO · Traditional | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 11/22/2018SE |
| K173771 | IOLMaster 700HJO · Traditional | Carl Zeiss Meditec, AG | 08/24/2018SE |
| K171877 | SLM-1ER, SLM-2ER, SLM-3ERHJO · Traditional | Chongqing Kanghua Ruiming S&T Co., Ltd. | 12/21/2017SE |
| K170470 | Digital Eye Anterior CameraHJO · Traditional | Medimaging Integrated Solution, Inc (Miis) | 10/06/2017SE |
| K162778 | Portable Slit Lamp MicroscopeHJO · Traditional | Suzhou Kangjie Medical, Inc. | 07/21/2017SE |
| K162684 | SL 220HJO · Traditional | Carl Zeiss Meditec, AG | 05/31/2017SE |
Questions and answers
When was Model SL-YZ5E cleared by the FDA?
Model SL-YZ5E (K962522) received a 510(k) decision of Substantially Equivalent on July 25, 1996, 41 days after the submission was received.
What is the product code of K962522?
The FDA product code is HJO – Biomicroscope, Slit-Lamp, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1850.