Cleared Traditional

Intense Pulse Light Therapeutic Apparatus (K232932) - FDA 510(k) Clearance

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

K232932 · Shenzhen Greatro Electronic Technology Co., Ltd. · General & Plastic Surgery device
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Dec 2023
Decision
75d
Days
Class 2
Risk

K232932 is an FDA 510(k) clearance for the Intense Pulse Light Therapeutic Apparatus. 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 December 4, 2023 after a review of 75 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 K232932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2023
Decision Date December 04, 2023
Days to Decision 75 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
40d faster than avg
Panel avg: 115d · This submission: 75d
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 K232932.
SmoothSkin Pure Adapt (SSG3)
K233782 · Cyden Limited · Dec 2023
IPL Hair Removal Device
K232939 · Shenzhen Borria Technology Co., Ltd. · Dec 2023
Light Based Hair Removal Device
K232846 · Shenzhen Meik Beauty Industry Co., Ltd. · Dec 2023
Hair Removal Device, Model(s): R2815-G Pro, R2815-G
K232575 · Shenzhen Jianchao Intelligent Technology Co., Ltd. · Nov 2023
IPL Cooling Hair Removal Device
K232845 · Shenzhen Siken 3D Technology Development Co., Ltd. · Nov 2023
IPL Hair Removal Device (LS-T106, LS-T107, LS-T108)
K232499 · Shenzhen Lescolton Electrical Appliance Co., Ltd. · Oct 2023