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BIOLIGHT PCD

by Biolight International AB

510(k) K011355

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK011355 Date17 Jan 2002ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ILY
Device Class
Class II
Regulation
21 CFR Part 890.5500
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

BIOLIGHT PCD is a physiotherapeutic care device designed for the prevention and rehabilitation of injuries in the locomotor apparatus. It is classified under product code ILY and regulation number 890.5500 as a physical medicine device. The device is intended to support therapeutic care through its associated treatment programs.

The BIOLIGHT PCD is supplied by Biolight International AB and was cleared through the FDA 510(k) process under K011355 with a substantially equivalent decision. It is marketed for use in the United States for injury prevention and rehabilitation. The device is associated with the Physical Medicine advisory committee and is cleared as a traditional 510(k) submission.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the BIOLIGHT PCD used for?

    The BIOLIGHT PCD is a physiotherapeutic care device intended for the prevention and rehabilitation of injuries in the locomotor apparatus. It supports therapeutic care through its associated treatment programs, helping maintain mobility and function during recovery. Its classification under product code ILY and regulation number 890.5500 confirms its role as a physical medicine device.

  • How is the BIOLIGHT PCD supplied and who distributes it?

    The BIOLIGHT PCD is supplied by Biolight International AB, a company based in Minneapolis, Minnesota. The device is marketed for use in the United States and is distributed through standard medical supply channels, with contact information available through the applicant listed in the regulatory filing.

  • Is the BIOLIGHT PCD a single-use or reusable device?

    The device data does not specify whether the BIOLIGHT PCD is single-use or reusable. As a physiotherapeutic care device intended for injury prevention and rehabilitation, it is likely designed for repeated clinical use, but users should consult the manufacturer’s instructions for specific handling and reuse guidelines.

  • What sizes or models are available for the BIOLIGHT PCD?

    The available specifications do not list different sizes or models for the BIOLIGHT PCD. The device is described as a single product under the name BIOLIGHT PCD, with no indication of variant configurations in the provided data.

  • How should the BIOLIGHT PCD be stored?

    Storage requirements for the BIOLIGHT PCD are not detailed in the provided device data. For proper storage conditions, users should refer to the manufacturer’s labeling or contact Biolight International AB directly for guidance on temperature, humidity, and environmental handling.