Cleared Traditional

Diode Laser Hair Removal (K230090) - FDA 510(k) Clearance

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

K230090 · Wuhan Lotuxs Technology Co., Ltd. · General & Plastic Surgery device
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Apr 2023
Decision
97d
Days
Class 2
Risk

K230090 is an FDA 510(k) clearance for the Diode Laser Hair Removal. Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Wuhan Lotuxs Technology Co., Ltd. (Wuhan, CN). The FDA issued a Cleared decision on April 19, 2023 after a review of 97 days - within the typical 510(k) review window.

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 Wuhan Lotuxs Technology Co., Ltd. devices

Submission Details

510(k) Number K230090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2023
Decision Date April 19, 2023
Days to Decision 97 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
18d faster than avg
Panel avg: 115d · This submission: 97d
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

Tacro Guangzhou Branch
Na Wu

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 K230090.
Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200
K230739 · Shenzhen Ionka Medical Technology Co., Ltd. · May 2023
Braun Skin i.expert
K230911 · Cyden Limited · Apr 2023
IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG
K230549 · Shenzhen Xiazhifeng Electronic Co., Ltd. · Apr 2023
IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG
K230122 · Shenzhen Ulike Smart Electronics Co., Ltd. · Apr 2023
IPL Cooling Hair Removal Device, Model(s): NBB01, NBB02
K230360 · Shenzhen Jizhimei Technology Co., Ltd. · Apr 2023
IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108
K230097 · Shenzhen Bsx Technology Electronics Co., Ltd. · Apr 2023