Cleared Special

K212907 - Aimanfun Lumea Comfort, A-2789/A-3588 (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K212907 · Kam Yuen Plastic Products , Ltd. · General & Plastic Surgery device
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Dec 2021
Decision
80d
Days
Class 2
Risk

K212907 is an FDA 510(k) clearance for the Aimanfun Lumea Comfort, A-2789/A-3588. Classified as Powered Light Based Non-laser Surgical Instrument With Thermal Effect (product code ONF), Class II - Special Controls.

Submitted by Kam Yuen Plastic Products , Ltd. (Zhongshan, CN). The FDA issued a Cleared decision on December 2, 2021 after a review of 80 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Kam Yuen Plastic Products , Ltd. devices

Submission Details

510(k) Number K212907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2021
Decision Date December 02, 2021
Days to Decision 80 days
Submission Type Special
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
34d faster than avg
Panel avg: 114d · This submission: 80d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Guangdong Jianda Medical Technology Co., Ltd.
Jett Lee

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 - ONF Powered Light Based Non-laser Surgical Instrument With Thermal Effect

All 72
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