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FDA 510(k)

IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)

K-Number: K221246 · 2022-07-07

Decision Date2022-07-07
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Semlamp Intelligent Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-07 under 510(k) number K221246. 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 IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)?

IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) is a medical device that received FDA 510(k) clearance on 2022-07-07. The listed applicant is Shenzhen Semlamp Intelligent Technology Co., Ltd.. The 510(k) number is K221246.

When did IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) receive FDA 510(k) clearance?

IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) received FDA 510(k) clearance on 2022-07-07, under 510(k) number K221246.

Who is the listed applicant for IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)?

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

What is the FDA product code for IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)?

The FDA product code for IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) is OHT.

Other records listing Shenzhen Semlamp Intelligent Technology Co., 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.

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.

Official Source

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