Amblyopia Trainer
FDA 510(k) K800112 · Life-Tech Instruments, Inc.
510(k) numberK800112
Submission
- Device name
- Amblyopia Trainer
- Applicant
- Life-Tech Instruments, Inc.
Mchenry, IL, US - Received
- January 16, 1980
- Decision date
- March 10, 1980
- 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 |
| K854383 | KeratoluxHPL · Traditional | Carl Zeiss, Inc. | 11/12/1985SE |
| K801381 | Fite Fixation Toy for Ocular ExamHPL · Traditional | Fite Engineering Corp. | 07/28/1980SE |
| K781313 | Vision-Stimulator, CamHPL · Traditional | Clement Clarke, Inc. | 01/26/1979SE |
More from Clement Clarke, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K812177 | Life-Tech #1857 Pressure/Polot ModuleEXQ · Traditional | 09/09/1981SE |
| K812179 | Life-Tech #1753 Biofeedback TrainerHCC · Traditional | 08/25/1981SE |
| K812180 | Life-Tech #5102 VisulabGWN · Traditional | 08/21/1981SE |
| K812178 | Life-Tech #'S 1106/1156 UrolabsFAP · Traditional | 08/13/1981SE |
| K790663 | Model 1750 Standing UrinalFFG · Traditional | 04/24/1979SE |
| K790664 | Model 1309 Audio MonitorIKN · Traditional | 04/23/1979SE |
| K781476 | Mular Gold Leaf Electrode Model 7501HLZ · Traditional | 11/15/1978SE |
| K781461 | Model 7320 Visual StimulatorGWE · Traditional | 11/08/1978SE |
| K781475 | Electrode Impedance Tester-Model 500GYA · Traditional | 09/07/1978SE |
| K781474 | Preamplifier Models 8101PI & 8102PIEWO · Traditional | 09/07/1978SE |
Questions and answers
When was Amblyopia Trainer cleared by the FDA?
Amblyopia Trainer (K800112) received a 510(k) decision of Substantially Equivalent on March 10, 1980, 54 days after the submission was received.
What is the product code of K800112?
The FDA product code is HPL – Device, Fixation, Ac-Powered, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.1290.