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FDA 510(k)

Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP

K-Number: K220138 · 2022-10-05

ApplicantLed Spa
Decision Date2022-10-05
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP is the device name listed in this FDA 510(k) record. The listed applicant is Led Spa. It received FDA 510(k) clearance on 2022-10-05 under 510(k) number K220138. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP?

Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP is a medical device that received FDA 510(k) clearance on 2022-10-05. The listed applicant is Led Spa. The 510(k) number is K220138.

When did Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP receive FDA 510(k) clearance?

Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP received FDA 510(k) clearance on 2022-10-05, under 510(k) number K220138.

Who is the listed applicant for Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP?

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

What is the FDA product code for Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP?

The FDA product code for Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP is GEI.

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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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