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FDA 510(k)

BIOLIGHT PCD

K-Number: K011355 · 2002-01-17

ApplicantBiolight International AB
Decision Date2002-01-17
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

BIOLIGHT PCD is the device name listed in this FDA 510(k) record. The listed applicant is Biolight International AB. It received FDA 510(k) clearance on 2002-01-17 under 510(k) number K011355. 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 PCD?

BIOLIGHT PCD is a medical device that received FDA 510(k) clearance on 2002-01-17. The listed applicant is Biolight International AB. The 510(k) number is K011355.

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

BIOLIGHT PCD received FDA 510(k) clearance on 2002-01-17, under 510(k) number K011355.

Who is the listed applicant for BIOLIGHT PCD?

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

What is the FDA product code for BIOLIGHT PCD?

The FDA product code for BIOLIGHT PCD is ILY.

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Related Devices (Code: 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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