510(k) K854383

KERATOLUX by Carl Zeiss, Inc. — Product Code HPL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 12, 1985
Date Received: October 30, 1985
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 Carl Zeiss, Inc.

K013402 — VISULAS 532S (November 14, 2001)
K003885 — VISULAS YAG II (February 22, 2001)
K993357 — IOLMASTER (March 20, 2000)
K983868 — OPMI TWINER SURGICAL MICROSCOPE (January 29, 1999)
K965139 — SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEM (April 23, 1997)
K961380 — CPC PROBE (March 17, 1997)
K961171 — HUMPHREY OCT SCANNER (June 21, 1996)
K954167 — HUMPHREY FIELD ANALYZER (HFA II) (November 24, 1995)
K952894 — VISULINK 900 ARGON (August 14, 1995)
K950985 — ZEISS ENDOLIVE STERO ENDOSCOPE (March 29, 1995)

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)
K801381 — FITE FIXATION TOY FOR OCULAR EXAM (July 28, 1980)
K800112 — AMBLYOPIA TRAINER (March 10, 1980)
K781313 — VISION-STIMULATOR, CAM (January 26, 1979)