Cleared Traditional

K220248 - Home use hair removal device

K220248 is an FDA 510(k) clearance for Home use hair removal device, manufactured by Shenzhen Mareal Tech 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 151-day FDA review.

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

FDA 510(k) Submission Details - K220248

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.

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 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 142
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