Microscope, Specular

Device Code: 4389

Product Code(s): NQE

Definition: Specular Microscopes Are Used For The Microscopic Imaging And Assessment Of The Corneal Endothelial Cell Layer In Vivo Or In Vitro.

Device Classification Information

• Device Type ID: 4389
• Device Name: Microscope, Specular
• Regulation Description: AC-powered Slitlamp Biomicroscope.
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED); Diagnostic And Surgical Devices Branch (DSDB)
• Submission Type: 510(k)
• CFR Regulation Number: 886.1850 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: NQE
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 10-72 ISO 15004-1 First Edition 2006-06-01
  Ophthalmic Instruments - Fundamental Requirements And Test Methods - Part 1: General Requirements Applicable To All Ophthalmic Instruments
• 10-102 ANSI Z80.36-2016
  American National Standard For Ophthalmics - Light Hazard Protection For Ophthalmic Instruments

Total Product Life Cycle

• Device Type ID: 4389
• Device: Microscope, Specular
• Product Code: NQE
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: AC-powered Slitlamp Biomicroscope.
• CFR Regulation Number: 886.1850 [🔎]

Premarket Reviews
Manufacturer	Decision
NIDEK CO
	SUBSTANTIALLY EQUIVALENT	2
NIDEK CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
TOMEY CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
TOPCON CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Nidek Inc	II	Sep-01-2016

TPLC Last Update: 2019-04-02 20:48:13