Class Class II

IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03 (K223524)

K223524 2023-02-16 Traditional
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Description

IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03 by Morlaser Shenzhen Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK223524
Clearance Date2023-02-16
Clearance TypeTraditional
Product CodeOHT
Regulation Number878.4810

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Predicate lineage for K223524

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03 (K223524) cites 3 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K221002IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04CShenzhen Ulike Smart Electronics Co...2022
K212318IPL Hair RemovalDongguan Define Beauty Electronic T...2022
K213041IPL Hair Removal, Model: OBT-02Glan Electronics Co., Ltd.2021

Trace the full predicate network for K223524

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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