Cleared Traditional

K232708 - Intense pulsed light therapy device (FDA 510(k) Clearance)

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

K232708 · Hebei Zhemai Technology Co., Ltd. · General & Plastic Surgery device
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Dec 2023
Decision
87d
Days
Class 2
Risk

K232708 is an FDA 510(k) clearance for the Intense pulsed light therapy device. Classified as Powered Light Based Non-laser Surgical Instrument With Thermal Effect (product code ONF), Class II - Special Controls.

Submitted by Hebei Zhemai Technology Co., Ltd. (Langfang, CN). The FDA issued a Cleared decision on December 1, 2023 after a review of 87 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 Hebei Zhemai Technology Co., Ltd. devices

Submission Details

510(k) Number K232708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2023
Decision Date December 01, 2023
Days to Decision 87 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
27d faster than avg
Panel avg: 114d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ONF Powered Light Based Non-laser Surgical Instrument With Thermal Effect
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition A Light Based Non-laser Device That Provides Thermal Effect Including Broad Spectrum Source Devices Such As Intense Pulse Light (ipl). Typically, Indicated To Be Used In Medical Specialties Of General And Plastic Surgery And Of Dermatology/aesthetic. Indication For Use Can Be General And/or Specific.the Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Or Remove Tissue By The Light.
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 - ONF Powered Light Based Non-laser Surgical Instrument With Thermal Effect

All 72
Devices cleared under the same product code (ONF) and FDA review panel - the closest regulatory comparables to K232708.
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