Cleared Traditional

Home use hair removal device (K220248) - FDA 510(k) Clearance

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

K220248 · Shenzhen Mareal Tech Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
151d
Days
Class 2
Risk

K220248 is an FDA 510(k) clearance for the Home use hair removal device. Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Shenzhen Mareal Tech Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 1, 2022 after a review of 151 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 Mareal Tech Co., Ltd. devices

Submission Details

510(k) Number K220248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2022
Decision Date July 01, 2022
Days to Decision 151 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 115d · This submission: 151d
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 Consultant

Feiying Drug & Medical Consulting Technical Service Group
Rain Yip

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K220248.
IPL hair removal
K221451 · Shenzhen Lizbella Technology Co.,Ltd · Aug 2022
IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136)
K221246 · Shenzhen Semlamp Intelligent Technology Co., Ltd. · Jul 2022
IPL Hair Remover, Model: G993, G996, G998 and G885
K221679 · Shenzhen Mywin Technology Co., Ltd. · Jul 2022
Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K
K221569 · Shenzhen Fansizhe Science And Technology Co., Ltd. · Jun 2022
IPL Hair Removal
K220927 · Shenzhen Qiaochengli Technology Co., Ltd. · Jun 2022
IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C
K221002 · Shenzhen Ulike Smart Electronics Co., Ltd. · Jun 2022