Duns Number:713383495
Device Description: The RS-1000 zoom slit lamps are designed for ophthalmic observation and microphotography. The RS-1000 zoom slit lamps are designed for ophthalmic observation and microphotography. These slit lamps feature zoom stereoscopic converging microscopes that can be used for ophthalmic observation.This equipment is intended for use by medical doctors and optometrists.Each instrument consists primarily of the main unit and the illumination power supply unit.consisting of:・Zoom Slit Lamp RS-1000 Main Body ・Breath Plate・Eyepiece 12.5X・Eyepiece with Reticle 12.5X・Wooden Table top with chin rest ・Power supply for Illumination P-300R・UL Power supply Cord Hospital Grade(120V)
Catalog Number
-
Brand Name
Zoom Slit Lamp
Version/Model Number
RS-1000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K060869
Product Code
HJO
Product Code Name
Biomicroscope, Slit-Lamp, Ac-Powered
Public Device Record Key
ec42eda3-2bb6-4691-a4a5-5c988cd32ad7
Public Version Date
April 08, 2022
Public Version Number
4
DI Record Publish Date
July 13, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |