Cleared Traditional

K221002 - IPL Hair Removal Device

K221002 is an FDA 510(k) clearance for IPL Hair Removal Device, manufactured by Shenzhen Ulike Smart Electronics 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 58-day FDA review.

K221002 · Shenzhen Ulike Smart Electronics Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2022
Decision
58d
Days
Class 2
Risk

K221002 is an FDA 510(k) clearance for the IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C. Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Shenzhen Ulike Smart Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 1, 2022 after a review of 58 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 Ulike Smart Electronics Co., Ltd. devices

FDA 510(k) Submission Details - K221002

510(k) Number K221002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2022
Decision Date June 01, 2022
Days to Decision 58 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
57d faster than avg
Panel avg: 115d · This submission: 58d
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

Feiying Drug & Medical Consulting Technical Service Group
Tracy Che

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 K221002.
Home use hair removal device
K220248 · Shenzhen Mareal Tech Co., Ltd. · Jul 2022
Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K
K221569 · Shenzhen Fansizhe Science And Technology Co., Ltd. · Jun 2022
IPL Hair Removal
K220927 · Shenzhen Qiaochengli Technology Co., Ltd. · Jun 2022
IPL HAIR REMOVAL HANDSET, Model: IPL-666
K220669 · Shenzhen Junbobeauty Technology Co., Ltd. · May 2022
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