Home / 510(k) Clearances / K110489

510(k) K110489

SLIT LAMP SL-2G by Topcon Medical Systems, Inc. — Product Code HJO

K110489 is an FDA 510(k) premarket notification submitted by Topcon Medical Systems, Inc. for the device "SLIT LAMP SL-2G". The FDA issued a decision of Substantially Equivalent on May 23, 2011. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850. Topcon Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2011
Date Received
February 22, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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 Topcon Medical Systems, Inc.

  • K182376 — Harmony (September 28, 2018)
  • K151952 — Synergy ODM (October 1, 2015)
  • K132438 — IMAGENET 5 PC SOFTWARE SYSTEM (October 17, 2013)
  • K132667 — SYNERGY ODM (October 9, 2013)
  • K123101 — TRC-50DX RETINAL CAMERA (June 5, 2013)
  • K123460 — TRC-NW300 NON-MYDRIATIC RETINAL CAMERA (February 6, 2013)
  • K093313 — SYNERGY (December 2, 2009)
  • K083316 — 3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM (March 13, 2009)
  • K072971 — TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINA (January 13, 2009)
  • K031831 — TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM (December 19, 2003)

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