Cleared Traditional

Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200 (K230739) - FDA 510(k) Clearance

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

K230739 · Shenzhen Ionka Medical Technology Co., Ltd. · General & Plastic Surgery device
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May 2023
Decision
70d
Days
Class 2
Risk

K230739 is an FDA 510(k) clearance for the Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-60.... Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Shenzhen Ionka Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 26, 2023 after a review of 70 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 Ionka Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K230739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2023
Decision Date May 26, 2023
Days to Decision 70 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
45d faster than avg
Panel avg: 115d · This submission: 70d
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 K230739.
IVYLASER Handhold Hair Removal Machine
K230025 · Ivylaser (Beijing) Technology Co.,Ltd · Jul 2023
IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S
K231215 · Zhongshan Qizhe Technology Co., Ltd. · Jun 2023
IPL Hair Removal Device Models: MLY-T069
K230473 · Miley Technology (Hebei) Co., Ltd. · Jun 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
Diode Laser Hair Removal
K230090 · Wuhan Lotuxs Technology Co., Ltd. · Apr 2023