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FDA 510(k)

TFX-LT2000 Therapy Light

K-Number: K211265 · 2022-11-17

ApplicantToefx, Inc.
Decision Date2022-11-17
Product CodePDZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TFX-LT2000 Therapy Light is the device name listed in this FDA 510(k) record. The listed applicant is Toefx, Inc.. It received FDA 510(k) clearance on 2022-11-17 under 510(k) number K211265. The device is classified under product code PDZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TFX-LT2000 Therapy Light?

TFX-LT2000 Therapy Light is a medical device that received FDA 510(k) clearance on 2022-11-17. The listed applicant is Toefx, Inc.. The 510(k) number is K211265.

When did TFX-LT2000 Therapy Light receive FDA 510(k) clearance?

TFX-LT2000 Therapy Light received FDA 510(k) clearance on 2022-11-17, under 510(k) number K211265.

Who is the listed applicant for TFX-LT2000 Therapy Light?

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

What is the FDA product code for TFX-LT2000 Therapy Light?

The FDA product code for TFX-LT2000 Therapy Light is PDZ.

Related Devices (Code: PDZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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