Cleared Traditional

K240482 - Intense Pulsed Light System (ST-690)

K240482 is an FDA 510(k) clearance for Intense Pulsed Light System (ST-690), manufactured by Smedtrum Medical Technology Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code ONF cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K240482 · Smedtrum Medical Technology Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2024
Decision
87d
Days
Class 2
Risk

K240482 is an FDA 510(k) clearance for the Intense Pulsed Light System (ST-690). Classified as Powered Light Based Non-laser Surgical Instrument With Thermal Effect (product code ONF), Class II - Special Controls.

Submitted by Smedtrum Medical Technology Co., Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on May 17, 2024 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 Smedtrum Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K240482

510(k) Number K240482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2024
Decision Date May 17, 2024
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
28d faster than avg
Panel avg: 115d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ONF Device Classification - Class 2, Special Controls

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 32
Devices cleared under the same product code (ONF) and FDA review panel - the closest regulatory comparables to K240482.
DEKA LOTUS
K250281 · El.En S.P.A. · Feb 2025
Intense Pulsed Light Treatment System (LK-PT)
K242440 · Nanjing Bestview Laser S&T Co., Ltd. · Nov 2024
MULA (K2-A1)
K240314 · Guangzhou Ciellulu Photoelectric Technology Co., Ltd. · Aug 2024
DEKA LOTUS
K233473 · El.En S.P.A. · May 2024
Intensity Pulsed Light Therapy System
K233307 · Beijing Adss Development Co., Ltd. · Mar 2024
Intense pulsed light therapy device
K232708 · Hebei Zhemai Technology Co., Ltd. · Dec 2023