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FDA 510(k)

BIOLIGHT BIODYNAM

K-Number: K130866 · 2013-10-25

ApplicantBiolight AB
Decision Date2013-10-25
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BIOLIGHT BIODYNAM is the device name listed in this FDA 510(k) record. The listed applicant is Biolight AB. It received FDA 510(k) clearance on 2013-10-25 under 510(k) number K130866. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOLIGHT BIODYNAM?

BIOLIGHT BIODYNAM is a medical device that received FDA 510(k) clearance on 2013-10-25. The listed applicant is Biolight AB. The 510(k) number is K130866.

When did BIOLIGHT BIODYNAM receive FDA 510(k) clearance?

BIOLIGHT BIODYNAM received FDA 510(k) clearance on 2013-10-25, under 510(k) number K130866.

Who is the listed applicant for BIOLIGHT BIODYNAM?

The FDA 510(k) record lists Biolight AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOLIGHT BIODYNAM?

The FDA product code for BIOLIGHT BIODYNAM is ILY.

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Official Source

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

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