Woodlyn Standard Slit Lamp Hssl-St
FDA 510(k) K841765 · Woodlyn, Inc.
510(k) numberK841765
Submission
- Device name
- Woodlyn Standard Slit Lamp Hssl-St
- Applicant
- Woodlyn, Inc.
Mchenry, IL, US - Received
- April 27, 1984
- Decision date
- August 7, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HLQ – Keratoscope, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1350
- Specialty
- Ophthalmic
Other 510(k)s with product code HLQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K003299 | Opd-Scan, Models ARK-10000 and ARK-9000HLQ · Traditional | Nidek Co., Ltd. | 03/09/2001SESU |
| K973756 | Eye Sys VistaHLQ · Traditional | Eyesys Technologies, Inc. | 11/13/1997SE |
| K964290 | EyechekHLQ · Traditional | Reichert Ophthalmic Instruments, Div. Leica, Inc. | 01/09/1997SE |
| K945382 | Technomed C-Scan Color Ellipsoid TopometerHLQ · Traditional | Expertech Assoc., Inc. | 01/31/1995SE |
| K944207 | Topographic Modeling System 2 TMS-2HLQ · Traditional | Computed Anatomy, Inc. | 12/07/1994SE |
| K944616 | Keratron Corneal TopographerHLQ · Traditional | Alliance Medical Marketinig | 11/22/1994SE |
| K940647 | Orbscan(Tm) KeratometerHLQ · Traditional | Orbtek, Inc. | 07/06/1994SE |
| K933556 | EH-270 Corneal TopographerHLQ · Traditional | Visioptic, Inc. | 11/02/1993SE |
| K923435 | Corneal Topography SystemHLQ · Traditional | Par Microsystems Corp. | 02/16/1993SE |
| K922253 | Keratoref L60HLQ · Traditional | Luneau Ophtalmologie SA | 06/19/1992SE |
More from Luneau Ophtalmologie SA
| 510(k) | Device | Decision |
|---|---|---|
| K931303 | Woodlyn Operation MicroscopeFSO · Traditional | 06/25/1993SE |
| K920861 | Woodlyn Classic LensmeterHLM · Traditional | 07/30/1992SE |
| K900478 | Woodlyn Full Aperture Trial Lens SetHPC · Traditional | 02/21/1990SE |
| K900477 | Woodlyn Classic Slit Lamp Model SMMHJO · Traditional | 02/21/1990SE |
| K900476 | Woodlyn Slit Lamp Model HR-1HJO · Traditional | 02/21/1990SE |
| K890992 | Woodlyn Ophthalmic ProjectorHOS · Traditional | 05/17/1989SE |
| K874900 | Woodlyn Classic Refractor, PhoroptorHKN · Traditional | 12/23/1987SE |
| K843812 | Woodlyn Classic Cataract Acuity TestHLI · Traditional | 12/11/1984SE |
| K841767 | Woodlyn Classic KeratometerHLI · Traditional | 08/07/1984SE |
| K841764 | Woodlyn Classic Javal OphthalmometerHLI · Traditional | 08/07/1984SE |
Questions and answers
When was Woodlyn Standard Slit Lamp Hssl-St cleared by the FDA?
Woodlyn Standard Slit Lamp Hssl-St (K841765) received a 510(k) decision of Substantially Equivalent on August 7, 1984, 102 days after the submission was received.
What is the product code of K841765?
The FDA product code is HLQ – Keratoscope, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.1350.