Keeler Slit Lamp
FDA 510(k) K151394 · Keeler Limited
510(k) numberK151394
Submission
- Device name
- Keeler Slit Lamp
- Applicant
- Keeler Limited
Windsor, GB - Received
- May 26, 2015
- Decision date
- September 10, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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|---|---|---|---|
| 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
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|---|---|---|
| K152644 | Keeler Disposable Tonomate, Keeler Disposable Tonomate, Box of 100HKY · Special | 12/31/2015SE |
| K142179 | D-Kat Z-YpeHKY · Special | 09/17/2014SE |
| K140451 | Keeler Slit Lamp H-Series Digital (Halogen Bulb Option), Keeler Slit Lamp H-Series…HJO · Traditional | 07/11/2014SE |
| K140450 | Keeler Kapture SoftwareHKI · Traditional | 06/17/2014SE |
| K133234 | T-Type D-Kat, R-Type D-KatHKY · Traditional | 02/21/2014SE |
| K131787 | Cryomatic Mkii Console, Cryomatic Mkii Probes, Disposable Cryo ProbesHRN · Special | 12/23/2013SE |
| K131589 | Keeler Slit Lamp H-SeriesHJO · Abbreviated | 06/27/2013SE |
| K093445 | Keeler Applanation Tonometer; T-Type Kat, K-Type Kat, (Kat)HKY · Abbreviated | 01/19/2010SE |
Questions and answers
When was Keeler Slit Lamp cleared by the FDA?
Keeler Slit Lamp (K151394) received a 510(k) decision of Substantially Equivalent on September 10, 2015, 107 days after the submission was received.
What is the product code of K151394?
The FDA product code is HJO – Biomicroscope, Slit-Lamp, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1850.