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FDA 510(k)

LASER-STIM

K-Number: K131259 · 2013-12-27

ApplicantShenzhen Dongdixin Technology Co., Ltd.
Decision Date2013-12-27
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

LASER-STIM is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. It received FDA 510(k) clearance on 2013-12-27 under 510(k) number K131259. 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 LASER-STIM?

LASER-STIM is a medical device that received FDA 510(k) clearance on 2013-12-27. The listed applicant is Shenzhen Dongdixin Technology Co., Ltd.. The 510(k) number is K131259.

When did LASER-STIM receive FDA 510(k) clearance?

LASER-STIM received FDA 510(k) clearance on 2013-12-27, under 510(k) number K131259.

Who is the listed applicant for LASER-STIM?

The FDA 510(k) record lists Shenzhen Dongdixin Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LASER-STIM?

The FDA product code for LASER-STIM is ILY.

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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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