Cleared Traditional

Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) (K242595) - FDA 510(k) Clearance

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

K242595 · Shenzhen Greatro Electronic Technology Co., Ltd. · General & Plastic Surgery device
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Nov 2024
Decision
69d
Days
Class 2
Risk

K242595 is an FDA 510(k) clearance for the Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG). Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Shenzhen Greatro Electronic Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on November 7, 2024 after a review of 69 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 Greatro Electronic Technology Co., Ltd. devices

Submission Details

510(k) Number K242595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2024
Decision Date November 07, 2024
Days to Decision 69 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
46d faster than avg
Panel avg: 115d · This submission: 69d
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 K242595.
Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP)
K241998 · Shenzhen Ulike Smart Electronics Co., Ltd. · Dec 2024
Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro)
K242710 · Shenzhen Jianchao Intelligent Technology Co., Ltd. · Dec 2024
SmoothSkin Pure Switch (SSC1)
K243362 · Cyden Limited · 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 (DH4, DH5, DH5 Plus, DH5 Max)
K242197 · Shenzhen Huaruibo Electric Appliances Co., Ltd. · Oct 2024