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510(k) K153545

Portable Slit Lamp by Shanghai Bolan Optical-Electric Co., Ltd. — Product Code HJO

K153545 is an FDA 510(k) premarket notification submitted by Shanghai Bolan Optical-Electric Co., Ltd. for the device "Portable Slit Lamp". The FDA issued a decision of Substantially Equivalent on June 22, 2016. The device falls under product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered), a Class II device regulated under 21 CFR 886.1850.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2016
Date Received
December 11, 2015
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

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  • 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)

FDA data resources