AR-1600 Automatic Refractor
FDA 510(k) K861062 · Nidek, Inc.
510(k) numberK861062
Submission
- Device name
- AR-1600 Automatic Refractor
- Applicant
- Nidek, Inc.
Palo Alto, CA, US - Received
- March 20, 1986
- Decision date
- April 4, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HKO – Refractometer, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1760
- Specialty
- Ophthalmic
Other 510(k)s with product code HKO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K031831 | Topcon Model BV-1000 Automated Subjective Refraction SystemHKO · Traditional | Topcon Medical Systems, Inc. | 12/19/2003SE |
| K000327 | Wavescan Wavefront System Model HS 1HKO · Traditional | Visx, Incorporated | 05/02/2000SESU |
| K951179 | Digital Retinoscopic PhotometerHKO · Traditional | Kudi Kalu, Inc. | 05/30/1995SE |
| K945959 | Video Vision Analyzer (Viva), VRB 100HKO · Traditional | Tomey Corporation USA | 03/01/1995SE |
| K942242 | Auto Ref-Keratometer, RK-3HKO · Traditional | Cannon U.S.A., Inc. | 09/02/1994SE |
| K940516 | Auto REFF-30HKO · Traditional | Canon, Inc. | 07/12/1994SE |
| K925304 | Autoref Lensmeter RL-10HKO · Traditional | Canon USA, Inc. | 02/17/1994SE |
| K924741 | Optec 3000HKO · Traditional | Stereo Optical Co., Inc. | 04/06/1993SE |
| K924790 | Burton Auto Refractor - Model BAR-7HKO · Traditional | R.H. Burton Co. | 04/05/1993SE |
| K924778 | Burton Auto Refractor/Keratometer - Model BARK-8HKO · Traditional | R.H. Burton Co. | 04/05/1993SE |
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| K170302 | Yellow Laser Photocoagulator YLC-500HQF · Traditional | 06/23/2017SE |
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Questions and answers
When was AR-1600 Automatic Refractor cleared by the FDA?
AR-1600 Automatic Refractor (K861062) received a 510(k) decision of Substantially Equivalent on April 4, 1986, 15 days after the submission was received.
What is the product code of K861062?
The FDA product code is HKO – Refractometer, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.1760.