Class Class II

Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) (K242595)

K242595 2024-11-07 Traditional
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Description

Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) by Shenzhen Greatro Electronic Technology Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK242595
Clearance Date2024-11-07
Clearance TypeTraditional
Product CodeOHT
Regulation Number878.4810

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Predicate lineage for K242595

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. Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) (K242595) cites 2 predicate devices and is itself cited by 1 later device.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K232932Intense Pulse Light Therapeutic ApparatusShenzhen Greatro Electronic Technol...2023
K223618IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 J...Shenzhen Ulike Smart Electronics Co...2023

Later devices that cite this one as their predicate

Devices that cite K242595
K numberDeviceApplicantYear
K251707IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L)Shenzhen Huachuangtong Industrial C...2025

Trace the full predicate network for K242595

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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