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FDA 510(k)

GLOW800

K-Number: K181537 · 2018-09-07

ApplicantLeica Microsystems (Schweiz) AG
Decision Date2018-09-07
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GLOW800 is a medical device manufactured by Leica Microsystems (Schweiz) AG. It received FDA 510(k) clearance on 2018-09-07 under approval number K181537. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLOW800?

GLOW800 is a medical device that received FDA 510(k) clearance on 2018-09-07. It is manufactured by Leica Microsystems (Schweiz) AG. The 510(k) number is K181537.

When was GLOW800 approved by the FDA?

GLOW800 received FDA 510(k) clearance on 2018-09-07, under approval number K181537.

What company makes GLOW800?

GLOW800 is manufactured by Leica Microsystems (Schweiz) AG.

What is the FDA product code for GLOW800?

The FDA product code for GLOW800 is IZI.

Other Devices by Leica Microsystems (Schweiz) AG

K170239Leica FL560 DEN180024Leica FL400

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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