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FDA 510(k)

IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130

K-Number: K192432 · 2019-11-08

Decision Date2019-11-08
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Bosidin Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-11-08 under 510(k) number K192432. 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 Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130?

IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130 is a medical device that received FDA 510(k) clearance on 2019-11-08. The listed applicant is Shenzhen Bosidin Technology Co., Ltd.. The 510(k) number is K192432.

When did IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130 receive FDA 510(k) clearance?

IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130 received FDA 510(k) clearance on 2019-11-08, under 510(k) number K192432.

Who is the listed applicant for IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130?

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

What is the FDA product code for IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130?

The FDA product code for IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130 is OHT.

Related Clinical Trials

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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