Home / 510(k) Clearances / K870203

510(k) K870203

KEELER LVA SYSTEM MULTI-CAP SERIES LVA51-1/2/3/4/5 by Keeler Instruments, Inc. — Product Code HKK

K870203 is an FDA 510(k) premarket notification submitted by Keeler Instruments, Inc. for the device "KEELER LVA SYSTEM MULTI-CAP SERIES LVA51-1/2/3/4/5". The FDA issued a decision of Substantially Equivalent on February 12, 1987. The device falls under product code HKK (Telescope, Spectacle, Low-Vision), a Class I device regulated under 21 CFR 886.5870. Keeler Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1987
Date Received
January 20, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Telescope, Spectacle, Low-Vision
Device Class
Class I
Regulation Number
886.5870
Review Panel
OP
Submission Type

Other clearances by Keeler Instruments, Inc.

  • K181143 — Keeler TonoCare Tonometer (February 8, 2019)
  • K112093 — CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER (December 8, 2011)
  • K093298 — PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000 (December 10, 2010)
  • K100500 — PSL CLASSIC SLIT LAMP (March 9, 2010)
  • K062412 — CRYOMATIC (November 6, 2006)
  • K060822 — VANTAGE INDIRECT OPHTHALMOSCOPE (May 23, 2006)
  • K032087 — KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 (November 26, 2003)
  • K992954 — KEELER CRYO MASTER & PROBES (December 21, 1999)
  • K990257 — KEELER PULSAIR 3000 NON CONTACT TONOMETER (March 25, 1999)
  • K973064 — KEELER TEARSCOPE-PLUS (April 7, 1998)

Other clearances for product code HKK

  • K864594 — DUALENZ LOW VISION EYEWEAR (January 20, 1987)

FDA data resources