Objective Refractor
FDA 510(k) K802029 · Zeiss Humphrey System
510(k) numberK802029
Submission
- Device name
- Objective Refractor
- Applicant
- Zeiss Humphrey System
Walker, MI, US - Received
- August 21, 1980
- Decision date
- November 12, 1980
- 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 |
More from R.H. Burton Co.
| 510(k) | Device | Decision |
|---|---|---|
| K942439 | Zeiss Opmilas 144 Surgical LasersGEX · Traditional | 07/01/1994SE |
| K923211 | Digital Ophthalmic Ultrasound BiomicroscopeIYO · Traditional | 11/08/1993SE |
| K923348 | Ophthalmic A/B Scan System, Model 835 -- ModifiedITX · Traditional | 12/10/1992SE |
| K852639 | Humphrey Field Analyzer Model 630HPT · Traditional | 09/18/1985SE |
| K852638 | Humphrey Image Analyzer Model 110HKI · Traditional | 08/12/1985SE |
| K821940 | The Humphrey Field Analyzer Model 610HPT · Traditional | 07/28/1982SE |
| K781994 | Autokeratometer, InstrumentHLQ · Traditional | 02/12/1979SE |
| K782096 | Instruments, Overrefraction SystemHLM · Traditional | 01/26/1979SE |
Questions and answers
When was Objective Refractor cleared by the FDA?
Objective Refractor (K802029) received a 510(k) decision of Substantially Equivalent on November 12, 1980, 83 days after the submission was received.
What is the product code of K802029?
The FDA product code is HKO – Refractometer, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.1760.