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FDA 510(k)

Beurer IPL 8500 device/ IPL VelvetSkin Pro

K-Number: K181734 · 2018-09-19

ApplicantHome Well Trading, Ltd.
Decision Date2018-09-19
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Beurer IPL 8500 device/ IPL VelvetSkin Pro is the device name listed in this FDA 510(k) record. The listed applicant is Home Well Trading, Ltd.. It received FDA 510(k) clearance on 2018-09-19 under 510(k) number K181734. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Beurer IPL 8500 device/ IPL VelvetSkin Pro?

Beurer IPL 8500 device/ IPL VelvetSkin Pro is a medical device that received FDA 510(k) clearance on 2018-09-19. The listed applicant is Home Well Trading, Ltd.. The 510(k) number is K181734.

When did Beurer IPL 8500 device/ IPL VelvetSkin Pro receive FDA 510(k) clearance?

Beurer IPL 8500 device/ IPL VelvetSkin Pro received FDA 510(k) clearance on 2018-09-19, under 510(k) number K181734.

Who is the listed applicant for Beurer IPL 8500 device/ IPL VelvetSkin Pro?

The FDA 510(k) record lists Home Well Trading, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Beurer IPL 8500 device/ IPL VelvetSkin Pro?

The FDA product code for Beurer IPL 8500 device/ IPL VelvetSkin Pro is OHT.

Other records listing Home Well Trading, Ltd. as applicant

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.

K181121Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro

Related Devices (Code: OHT)

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.

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Official Source

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