Burton Trial Lens Set
FDA 510(k) K924786 · R.H. Burton Co.
510(k) numberK924786
Submission
- Device name
- Burton Trial Lens Set
- Applicant
- R.H. Burton Co.
Grove City, OH, US - Received
- September 23, 1992
- Decision date
- April 14, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| K920571 | Trial Lens SetHPC · Traditional | R.H. Burton Co. | 05/07/1992SE |
| K900478 | Woodlyn Full Aperture Trial Lens SetHPC · Traditional | Woodlyn, Inc. | 02/21/1990SE |
| 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 |
|---|---|---|
| K924773 | Burton H- Base Table - Model 1990HRX · Traditional | 06/07/1993SE |
| K924783 | Burton Slit Lamp - Model 850HJO · Traditional | 04/14/1993SE |
| K924774 | Burton Automatic Projector - Model CP-40HOD · Traditional | 04/14/1993SE |
| K924790 | Burton Auto Refractor - Model BAR-7HKO · Traditional | 04/05/1993SE |
| K924788 | Burton LensmeterHLM · Traditional | 04/05/1993SE |
| K924785 | Burton Radiusgauge - Model 2030HLM · Traditional | 04/05/1993SE |
| K924784 | Burton Projector Head - Model 6000-HHOS · Traditional | 04/05/1993SE |
| K924780 | Burton Ophthalmic Exam Unit - Model 2201HMF · Traditional | 04/05/1993SE |
| K924779 | Burton Keratometer - Modle 2040HJB · Traditional | 04/05/1993SE |
| K924778 | Burton Auto Refractor/Keratometer - Model BARK-8HKO · Traditional | 04/05/1993SE |
Questions and answers
When was Burton Trial Lens Set cleared by the FDA?
Burton Trial Lens Set (K924786) received a 510(k) decision of Substantially Equivalent on April 14, 1993, 203 days after the submission was received.
What is the product code of K924786?
The FDA product code is HPC – Set, Lens, Trial, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.1405.