Cleared Traditional

Planar LED mate (K230362) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230362 · Shenzhen Leaflife Technology Co., Ltd. · General & Plastic Surgery device
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Sep 2023
Decision
213d
Days
Class 2
Risk

K230362 is an FDA 510(k) clearance for the Planar LED mate. Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Shenzhen Leaflife Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 11, 2023 after a review of 213 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Leaflife Technology Co., Ltd. devices

Submission Details

510(k) Number K230362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2023
Decision Date September 11, 2023
Days to Decision 213 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 115d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OHT Light Based Over-the-counter Hair Removal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition Over-the-counter Device Uses Thermal Energy To Kill Hair Follicles For Hair Removal.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OHT Light Based Over-the-counter Hair Removal

All 141
Devices cleared under the same product code (OHT) and FDA review panel - the closest regulatory comparables to K230362.
PEACH 2, PEACH 2 Duo, PEACH 2 go
K231977 · Foreo, Inc. · Sep 2023
IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10
K232183 · Shenzhen Koli Technology Co.,Ltd · Sep 2023
IPL Hair Removal, Model: W-1095, W-1098
K232124 · Shenzhen Wochuan Electronic Co., Ltd. · Sep 2023
IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9
K231800 · Shenzhen Qianyu Technology Co., Ltd. · Sep 2023
IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022
K231717 · Foshan Jindi Electric Appliance Co., Ltd. · Sep 2023
Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.
K231613 · Zhuzhou Goldenhot Medical Technology Co., Ltd. · Jul 2023