PSL Portable Slit Lamp
FDA 510(k) K061330 · Reichert, Inc.
510(k) numberK061330
Submission
- Device name
- PSL Portable Slit Lamp
- Applicant
- Reichert, Inc.
Depew, NY, US - Received
- May 12, 2006
- Decision date
- May 25, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement available from FDA
- Third-party review
- Yes
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 |
More from Carl Zeiss Meditec, AG
| 510(k) | Device | Decision |
|---|---|---|
| K233516 | Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318)HKY · Traditional | 05/01/2024SE |
| K141954 | Xcel 455 Slit LampHJO · Special | 10/15/2014SE |
| K081756 | Ocular Response AnalyzerHKX · Traditional | 08/07/2008SE |
| K071839 | Soct Copernicus, Model 15205OBO · Traditional | 02/27/2008SE |
| K070534 | Modification to: Ocu-Film Tip CoverHKY · Special | 03/27/2007SE |
| K063750 | Xcel 255 Slit LampHJO · Traditional | 12/20/2006SE |
| K042831 | Atp (Auto Non-Contact Tonometer/Pachymeter)IYO · Traditional | 10/28/2004SE |
| K032799 | Non-Contact Tonometers, Ocular Response AnalyzerHKX · Traditional | 01/20/2004SE |
Questions and answers
When was PSL Portable Slit Lamp cleared by the FDA?
PSL Portable Slit Lamp (K061330) received a 510(k) decision of Substantially Equivalent on May 25, 2006, 13 days after the submission was received.
What is the product code of K061330?
The FDA product code is HJO – Biomicroscope, Slit-Lamp, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1850.