PSL Classic Slit Lamp
FDA 510(k) K100500 · Keeler Instruments, Inc.
510(k) numberK100500
Submission
- Device name
- PSL Classic Slit Lamp
- Applicant
- Keeler Instruments, Inc.
Broomall, PA, US - Received
- February 22, 2010
- Decision date
- March 9, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K181143 | Keeler TonoCare TonometerHKX · Traditional | 02/08/2019SE |
| K112093 | Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe AdapterHRN · Special | 12/08/2011SE |
| K093298 | Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000HKX · Traditional | 12/10/2010SE |
| K062412 | CryomaticHRN · Traditional | 11/06/2006SE |
| K060822 | Vantage Indirect OphthalmoscopeHLI · Special | 05/23/2006SE |
| K032087 | Keeler Wide Angle Ophthalmoscope Model 1130-P-5004HLJ · Traditional | 11/26/2003SE |
| K992954 | Keeler Cryo Master & ProbesHRN · Traditional | 12/21/1999SE |
| K990257 | Keeler Pulsair 3000 Non Contact TonometerHKX · Traditional | 03/25/1999SE |
| K973064 | Keeler Tearscope-PlusHJO · Traditional | 04/07/1998SE |
| K970029 | Keeler Spectra Indirect OphthalmoscopeHLJ · Traditional | 04/02/1997SE |
Questions and answers
When was PSL Classic Slit Lamp cleared by the FDA?
PSL Classic Slit Lamp (K100500) received a 510(k) decision of Substantially Equivalent on March 9, 2010, 15 days after the submission was received.
What is the product code of K100500?
The FDA product code is HJO – Biomicroscope, Slit-Lamp, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1850.