Cleared Traditional

IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S (K231215) - FDA 510(k) Clearance

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

K231215 · Zhongshan Qizhe Technology Co., Ltd. · General & Plastic Surgery device
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Jun 2023
Decision
59d
Days
Class 2
Risk

K231215 is an FDA 510(k) clearance for the IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S. Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Zhongshan Qizhe Technology Co., Ltd. (Zhongshan, CN). The FDA issued a Cleared decision on June 26, 2023 after a review of 59 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 Zhongshan Qizhe Technology Co., Ltd. devices

Submission Details

510(k) Number K231215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2023
Decision Date June 26, 2023
Days to Decision 59 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
56d faster than avg
Panel avg: 115d · This submission: 59d
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

Qimmiq Medical Consulting Service Co., Ltd.
You Yijie

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 K231215.
IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022
K231717 · Foshan Jindi Electric Appliance Co., Ltd. · Sep 2023
Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G.
K231613 · Zhuzhou Goldenhot Medical Technology Co., Ltd. · Jul 2023
IVYLASER Handhold Hair Removal Machine
K230025 · Ivylaser (Beijing) Technology Co.,Ltd · Jul 2023
IPL Hair Removal Device Models: MLY-T069
K230473 · Miley Technology (Hebei) Co., Ltd. · Jun 2023
Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200
K230739 · Shenzhen Ionka Medical Technology Co., Ltd. · May 2023
Braun Skin i.expert
K230911 · Cyden Limited · Apr 2023