Cleared Traditional

K230090 - Diode Laser Hair Removal

K230090 is an FDA 510(k) clearance for Diode Laser Hair Removal, manufactured by Wuhan Lotuxs 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 97-day FDA review.

K230090 · Wuhan Lotuxs Technology Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K230090

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.

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

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 142
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
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K230911 · Cyden Limited · Apr 2023
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IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108
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