Cleared Traditional

K230362 - Planar LED mate

K230362 is an FDA 510(k) clearance for Planar LED mate, manufactured by Shenzhen Leaflife Technology Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code OHT cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K230362 · Shenzhen Leaflife Technology Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K230362

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.

OHT Device Classification - Class 2, Special Controls

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 142
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