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FDA 510(k)

DIOWAVE LOW LEVEL COLD LASER SYSTEM

K-Number: K121363 · 2012-11-23

ApplicantTechnological Medical Advancments, Inc. (Tma)
Decision Date2012-11-23
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DIOWAVE LOW LEVEL COLD LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Technological Medical Advancments, Inc. (Tma). It received FDA 510(k) clearance on 2012-11-23 under 510(k) number K121363. 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 DIOWAVE LOW LEVEL COLD LASER SYSTEM?

DIOWAVE LOW LEVEL COLD LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2012-11-23. The listed applicant is Technological Medical Advancments, Inc. (Tma). The 510(k) number is K121363.

When did DIOWAVE LOW LEVEL COLD LASER SYSTEM receive FDA 510(k) clearance?

DIOWAVE LOW LEVEL COLD LASER SYSTEM received FDA 510(k) clearance on 2012-11-23, under 510(k) number K121363.

Who is the listed applicant for DIOWAVE LOW LEVEL COLD LASER SYSTEM?

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

What is the FDA product code for DIOWAVE LOW LEVEL COLD LASER SYSTEM?

The FDA product code for DIOWAVE LOW LEVEL COLD LASER SYSTEM is 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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