510(k) K800112

AMBLYOPIA TRAINER by Life-Tech Instruments, Inc. — Product Code HPL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 10, 1980
Date Received: January 16, 1980
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Device, Fixation, Ac-Powered, Ophthalmic
Device Class: Class I
Regulation Number: 886.1290
Review Panel: OP
Submission Type

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 clearances by Life-Tech Instruments, Inc.

K812177 — LIFE-TECH #1857 PRESSURE/POLOT MODULE (September 9, 1981)
K812179 — LIFE-TECH #1753 BIOFEEDBACK TRAINER (August 25, 1981)
K812180 — LIFE-TECH #5102 VISULAB (August 21, 1981)
K812178 — LIFE-TECH #'S 1106/1156 UROLABS (August 13, 1981)
K790663 — MODEL 1750 STANDING URINAL (April 24, 1979)
K790664 — MODEL 1309 AUDIO MONITOR (April 23, 1979)
K781476 — MULAR GOLD LEAF ELECTRODE MODEL 7501 (November 15, 1978)
K781461 — MODEL 7320 VISUAL STIMULATOR (November 8, 1978)
K781474 — PREAMPLIFIER MODELS 8101PI & 8102PI (September 7, 1978)
K781475 — ELECTRODE IMPEDANCE TESTER-MODEL 500 (September 7, 1978)

Other clearances for product code HPL

K931731 — STORZ M824 FIXATION DEVICE FOR RETRACTIVE SURGERY (August 29, 1994)
K933739 — 360 DEGREE FIXATION LIGHT (March 14, 1994)
K873914 — ANIMATED FIXATION TOYS (DISTANCE AND NEARPOINT) (December 11, 1987)
K854383 — KERATOLUX (November 12, 1985)
K801381 — FITE FIXATION TOY FOR OCULAR EXAM (July 28, 1980)
K781313 — VISION-STIMULATOR, CAM (January 26, 1979)