Cleared Traditional

K212881 - Intense Pulsed Light (IPL) System

K212881 is an FDA 510(k) clearance for Intense Pulsed Light (IPL) System, manufactured by Shenzhen Fansizhe Science And Technology Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code OHT cleared through the Traditional 510(k) pathway after a 213-day FDA review.

K212881 · Shenzhen Fansizhe Science And Technology Co., Ltd. · General & Plastic Surgery device
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Apr 2022
Decision
213d
Days
Class 2
Risk

K212881 is an FDA 510(k) clearance for the Intense Pulsed Light (IPL) System. Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Shenzhen Fansizhe Science And Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 11, 2022 after a review of 213 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Fansizhe Science And Technology Co., Ltd. devices

FDA 510(k) Submission Details - K212881

510(k) Number K212881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2021
Decision Date April 11, 2022
Days to Decision 213 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 115d · This submission: 213d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OHT Device Classification - Class 2, Special Controls

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.
Jet You

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 142
Devices cleared under the same product code (OHT) and FDA review panel - the closest regulatory comparables to K212881.
IPL Home Use Hair Removal Device
K221001 · Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd. · May 2022
Hand-held IPL device (JOVS Hair Removal Device)
K220645 · Shenzhen Qianyu Technology Co., Ltd. · Apr 2022
IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4
K220222 · Shenzhen Yuwei Electronic Technology Co., Ltd. · Apr 2022
Hand-held IPL device(JOVS Graphene Hair Removal Device)
K214113 · Shenzhen Qianyu Technology Co., Ltd. · Mar 2022
Home use hair removal device, model: Precise Touch Pro
K213830 · Iluminage Beauty Co., Limited · Feb 2022
SmoothSkin Pure Mini
K213692 · Cyden Limited · Jan 2022