Panels › Ophthalmic › Product code HKN · Class 1
Refractor, Manual, Non-Powered, Including Phoropter
Regulation 886.1770
0510(k)s in 12 months (3 all time)
0recalls in 12 months (7 all time)
0recalls that name a 510(k)
Top companies in HKN
| Company | 510(k)s | Recalls |
|---|---|---|
| Nidek Inc | 0 | 3 |
| Reichert, Inc. | 0 | 3 |
| American Optical Corp. | 1 | 0 |
| Canon USA, Inc. | 1 | 0 |
| Reliance Medical Products Inc | 0 | 1 |
| Woodlyn, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2025 | Reichert, Inc. Phoroptor VRx Digital Refraction System
Model Numbers: 16242 Open, Classified |
HKN | None listed |
| Mar 31, 2025 | Reichert, Inc. Phoroptor VRx Digital Refraction System
Model Numbers: 16241 Open, Classified |
HKN | None listed |
| Aug 31, 2023 | Reichert, Inc. PHOROPTOR VRX DIGITAL REFRACTION SYSTEM-Digital refractor intended for the subjective measurement of the refractive error of the eye.
MODEL NUMBER: 16242
[Model 16241 is the base model. Model 16242 i Open, Classified |
HKN | None listed |
| Jun 14, 2018 | Nidek Inc. RT-5100 Refractor, a component of the Epic-5100 System. Terminated |
HKN | None listed |
| Dec 6, 2017 | Reliance Medical Products Inc Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07)
The Intended use of this medical device, as part of system to store and position ophthalmological examination and diagnostic equipment, is Terminated |
HKN | None listed |
| Mar 24, 2016 | Nidek Inc RT-5100 (Epic 5100) Refractor and RT 3100 Refractor:
Product Usage:
Instrument providing means of positioning spherical and cylindrical lenses, prisms and other optical devices in front of a subjects Terminated |
HKN | None listed |
| Jun 23, 2014 | Nidek Inc RT-5100 Refractor and RT-3100 Refractor;
Distributed by MARCO Opthalmic:
Manufactured by NIDEK CO., Ltd., Aichi, Japan.
Instrument provides means of positioning spherical and cylindrical lenses, pri Terminated |
HKN | None listed |
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