Woodlyn Classic Lensmeter
FDA 510(k) K920861 · Woodlyn, Inc.
510(k) numberK920861
Submission
- Device name
- Woodlyn Classic Lensmeter
- Applicant
- Woodlyn, Inc.
Arlington Heights, IL, US - Received
- February 25, 1992
- Decision date
- July 30, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HLM – Instrument, Measuring, Lens, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1425
- Specialty
- Ophthalmic
Other 510(k)s with product code HLM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K944022 | LenschekHLM · Traditional | Leica, Inc. | 11/17/1994SE |
| K940997 | AL-3300HLM · Traditional | Hoya Corp. USA | 09/29/1994SE |
| K936199 | Automatic LensometerHLM · Traditional | Canon USA, Inc. | 09/28/1994SE |
| K930441 | Marco Standard Lensmeters 101,201HLM · Traditional | Marco Ophthalmic, Inc. | 07/06/1993SE |
| K930445 | Marco LM-770 Digital Projection LensmeterHLM · Traditional | Marco Ophthalmic, Inc. | 06/21/1993SE |
| K924788 | Burton LensmeterHLM · Traditional | R.H. Burton Co. | 04/05/1993SE |
| K924785 | Burton Radiusgauge - Model 2030HLM · Traditional | R.H. Burton Co. | 04/05/1993SE |
| K924776 | Burton Lensmeter - Model 2021HLM · Traditional | R.H. Burton Co. | 04/05/1993SE |
| K884188 | Nidek LM-870 Automatic LensmeterHLM · Traditional | Nidek, Inc. | 11/23/1988SE |
| K862518 | Bausch & Lomb Vertometer V-5HLM · Traditional | Bausch & Lomb, Inc. | 08/11/1986SE |
More from Bausch & Lomb, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K931303 | Woodlyn Operation MicroscopeFSO · Traditional | 06/25/1993SE |
| 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 |
| K841765 | Woodlyn Standard Slit Lamp Hssl-StHLQ · Traditional | 08/07/1984SE |
| K841764 | Woodlyn Classic Javal OphthalmometerHLI · Traditional | 08/07/1984SE |
Questions and answers
When was Woodlyn Classic Lensmeter cleared by the FDA?
Woodlyn Classic Lensmeter (K920861) received a 510(k) decision of Substantially Equivalent on July 30, 1992, 156 days after the submission was received.
What is the product code of K920861?
The FDA product code is HLM – Instrument, Measuring, Lens, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.1425.