Woodlyn Full Aperture Trial Lens Set
FDA 510(k) K900478 · Woodlyn, Inc.
510(k) numberK900478
Submission
- Device name
- Woodlyn Full Aperture Trial Lens Set
- Applicant
- Woodlyn, Inc.
Arlington Heights, IL, US - Received
- February 1, 1990
- Decision date
- February 21, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HPC – Set, Lens, Trial, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1405
- Specialty
- Ophthalmic
Other 510(k)s with product code HPC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K945443 | Bobes Lens SetHPC · Traditional | Bobes S.A. | 07/19/1995SE |
| K951437 | Oti Model TLS-60HPC · Traditional | Oti Medical, LLC | 04/11/1995SE |
| K930195 | Ophthalmic Trial LensesHPC · Traditional | Optimark Accessories and Instruments | 01/06/1994SE |
| K934859 | Contact LensesHPC · Traditional | Arno Intl., Inc. | 12/21/1993SE |
| K930446 | Marco Trial SetsHPC · Traditional | Marco Ophthalmic, Inc. | 07/06/1993SE |
| K924786 | Burton Trial Lens SetHPC · Traditional | R.H. Burton Co. | 04/14/1993SE |
| K920571 | Trial Lens SetHPC · Traditional | R.H. Burton Co. | 05/07/1992SE |
| K873907 | Confirmation TestsHPC · Traditional | Richmond Products, Inc. | 12/29/1987SE |
| K852056 | Acc Cross CylindersHPC · Traditional | Ascon Medical Instruments, Ltd. | 06/05/1985SE |
| K843095 | Tria Lens SetHPC · Traditional | Optek Medico Co., Ltd. | 10/05/1984SE |
More from Optek Medico Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K931303 | Woodlyn Operation MicroscopeFSO · Traditional | 06/25/1993SE |
| K920861 | Woodlyn Classic LensmeterHLM · Traditional | 07/30/1992SE |
| 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 Full Aperture Trial Lens Set cleared by the FDA?
Woodlyn Full Aperture Trial Lens Set (K900478) received a 510(k) decision of Substantially Equivalent on February 21, 1990, 20 days after the submission was received.
What is the product code of K900478?
The FDA product code is HPC – Set, Lens, Trial, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.1405.