Cleared Traditional

IPL Hair Removal Device (K232939) - FDA 510(k) Clearance

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

K232939 · Shenzhen Borria Technology Co., Ltd. · General & Plastic Surgery device
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Dec 2023
Decision
86d
Days
Class 2
Risk

K232939 is an FDA 510(k) clearance for the IPL Hair Removal Device. Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Shenzhen Borria Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on December 15, 2023 after a review of 86 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shenzhen Borria Technology Co., Ltd. devices

Submission Details

510(k) Number K232939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2023
Decision Date December 15, 2023
Days to Decision 86 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
29d faster than avg
Panel avg: 115d · This submission: 86d
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
Bing Huang

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 K232939.
IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY,UI06 IG,)
K233664 · Shenzhen Ulike Smart Electronics Co., Ltd. · Jan 2024
IPL Hair Removal Device (UI04 MK,UI04 BN,UI04 BU,UI04 CB,UI04 GY,UI04 LG,UI04 DG,UI04 PL,UI04 PN,UI04 SD,UI04 SG,UI04 MG)
K233679 · Shenzhen Ulike Smart Electronics Co., Ltd. · Jan 2024
SmoothSkin Pure Adapt (SSG3)
K233782 · Cyden Limited · Dec 2023
Light Based Hair Removal Device
K232846 · Shenzhen Meik Beauty Industry Co., Ltd. · Dec 2023
Intense Pulse Light Therapeutic Apparatus
K232932 · Shenzhen Greatro Electronic Technology Co., Ltd. · Dec 2023
Hair Removal Device, Model(s): R2815-G Pro, R2815-G
K232575 · Shenzhen Jianchao Intelligent Technology Co., Ltd. · Nov 2023