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FDA 510(k)

MLT-1000 IR LASER SYSTEM

K-Number: K033986 · 2004-03-29

Decision Date2004-03-29
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MLT-1000 IR LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Laser Therapeutics LP. It received FDA 510(k) clearance on 2004-03-29 under 510(k) number K033986. 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 MLT-1000 IR LASER SYSTEM?

MLT-1000 IR LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2004-03-29. The listed applicant is Medical Laser Therapeutics LP. The 510(k) number is K033986.

When did MLT-1000 IR LASER SYSTEM receive FDA 510(k) clearance?

MLT-1000 IR LASER SYSTEM received FDA 510(k) clearance on 2004-03-29, under 510(k) number K033986.

Who is the listed applicant for MLT-1000 IR LASER SYSTEM?

The FDA 510(k) record lists Medical Laser Therapeutics LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MLT-1000 IR LASER SYSTEM?

The FDA product code for MLT-1000 IR LASER SYSTEM is ILY.

Related Clinical Trials

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.

Related Devices (Code: ILY)

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.

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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