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510(k) K100500

PSL CLASSIC SLIT LAMP by Keeler Instruments, Inc. — Product Code HJO

K100500 is an FDA 510(k) premarket notification submitted by Keeler Instruments, Inc. for the device "PSL CLASSIC SLIT LAMP". The FDA issued a decision of Substantially Equivalent on March 9, 2010. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Keeler Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2010
Date Received
February 22, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Biomicroscope, Slit-Lamp, Ac-Powered
Device Class
Class II
Regulation Number
886.1850
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)
  • 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)
  • K970029 — KEELER SPECTRA INDIRECT OPHTHALMOSCOPE (April 2, 1997)

Other clearances for product code HJO

  • K253834 — VISUREF 600 (March 18, 2026)
  • K231760 — HP-OCT (HP-OCT) (March 8, 2024)
  • K222372 — Kowa SL-19 (November 21, 2022)
  • K193188 — MiiS Horus Eye Anterior Camera (January 14, 2020)
  • K182306 — Sunkingdom Slit Lamp (November 22, 2018)
  • K173771 — IOLMaster 700 (August 24, 2018)
  • K171877 — SLM-1ER, SLM-2ER, SLM-3ER (December 21, 2017)
  • K170470 — Digital Eye Anterior Camera (October 6, 2017)
  • K162778 — Portable Slit Lamp Microscope (July 21, 2017)
  • K162684 — SL 220 (May 31, 2017)

FDA data resources