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FDA 510(k)

THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM

K-Number: K050342 · 2005-07-11

ApplicantTheralase, Inc.
Decision Date2005-07-11
Product CodeNHN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Theralase, Inc.. It received FDA 510(k) clearance on 2005-07-11 under 510(k) number K050342. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM?

THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2005-07-11. The listed applicant is Theralase, Inc.. The 510(k) number is K050342.

When did THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM receive FDA 510(k) clearance?

THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM received FDA 510(k) clearance on 2005-07-11, under 510(k) number K050342.

Who is the listed applicant for THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM?

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

What is the FDA product code for THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM?

The FDA product code for THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM is NHN.

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Related Devices (Code: NHN)

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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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