Keratolux
FDA 510(k) K854383 · Carl Zeiss, Inc.
510(k) numberK854383
Submission
- Device name
- Keratolux
- Applicant
- Carl Zeiss, Inc.
Thornwood, NY, US - Received
- October 30, 1985
- Decision date
- November 12, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HPL – Device, Fixation, Ac-Powered, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1290
- Specialty
- Ophthalmic
A fixation device is an AC-powered device intended for use as a fixation target for the patient during ophthalmologic examination. The patient directs his or her gaze so that the visual image of the object falls on the fovea centralis (the center of the macular retina of the eye.)
Other 510(k)s with product code HPL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K931731 | Storz M824 Fixation Device for Retractive SurgeryHPL · Traditional | Storz Instrument Co. | 08/29/1994SE |
| K933739 | 360 Degree Fixation LightHPL · Traditional | Varitronics | 03/14/1994SE |
| K873914 | Animated Fixation Toys (Distance and Nearpoint)HPL · Traditional | Richmond Products, Inc. | 12/11/1987SE |
| K801381 | Fite Fixation Toy for Ocular ExamHPL · Traditional | Fite Engineering Corp. | 07/28/1980SE |
| K800112 | Amblyopia TrainerHPL · Traditional | Life-Tech Instruments, Inc. | 03/10/1980SE |
| K781313 | Vision-Stimulator, CamHPL · Traditional | Clement Clarke, Inc. | 01/26/1979SE |
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| K993357 | IolmasterHJO · Traditional | 03/20/2000SE |
| K983868 | Opmi Twiner Surgical MicroscopeGEX · Traditional | 01/29/1999SE |
| K965139 | Surgical Microscope Navigator (SMN) System/Surgical Tool Navigator (STN) SystemHAW · Traditional | 04/23/1997SE |
| K961380 | CPC ProbeGEX · Traditional | 03/17/1997SE |
| K961171 | Humphrey Oct ScannerHLI · Traditional | 06/21/1996SE |
| K954167 | Humphrey Field Analyzer (Hfa II)HPT · Traditional | 11/24/1995SE |
| K952894 | Visulink 900 ArgonHQF · Traditional | 08/14/1995SE |
| K950985 | Zeiss Endolive Stero EndoscopeGCJ · Traditional | 03/29/1995SE |
Questions and answers
When was Keratolux cleared by the FDA?
Keratolux (K854383) received a 510(k) decision of Substantially Equivalent on November 12, 1985, 13 days after the submission was received.
What is the product code of K854383?
The FDA product code is HPL – Device, Fixation, Ac-Powered, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.1290.