Cleared Traditional

IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max) (K242197) - FDA 510(k) Clearance

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

K242197 · Shenzhen Huaruibo Electric Appliances Co., Ltd. · General & Plastic Surgery device
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Oct 2024
Decision
83d
Days
Class 2
Risk

K242197 is an FDA 510(k) clearance for the IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max). Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Shenzhen Huaruibo Electric Appliances Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 17, 2024 after a review of 83 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 Huaruibo Electric Appliances Co., Ltd. devices

Submission Details

510(k) Number K242197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2024
Decision Date October 17, 2024
Days to Decision 83 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 115d · This submission: 83d
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 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 K242197.
Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG)
K242595 · Shenzhen Greatro Electronic Technology Co., Ltd. · Nov 2024
Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR)
K242039 · Shenzhen Ulike Smart Electronics Co., Ltd. · Nov 2024
Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)
K243030 · Ulike Co., Ltd. · Oct 2024
IPL Hair Removal Device (BE932C, BE932D, BE932E)
K241834 · Shenzhen Yang WO Electronic Co., Ltd. · Sep 2024
Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE)
K241205 · Shenzhen Ulike Smart Electronics Co., Ltd. · Sep 2024
IPL Hair Removal Device (JM-843, JM-865, JM-638)
K241881 · Shenzhen Junmei Technology Co., Ltd. · Aug 2024