Cleared Traditional

IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22, BHRL-23, BHRL-24, BHRL-25, BHRL-26, BHRL-27, BHRL-28, BHRL-29) (K243036) - FDA 510(k) Clearance

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

K243036 · Bestway Plastic and Metal Products , Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2025
Decision
261d
Days
Class 2
Risk

K243036 is an FDA 510(k) clearance for the IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06.... Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Bestway Plastic and Metal Products , Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 15, 2025 after a review of 261 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 Bestway Plastic and Metal Products , Ltd. devices

Submission Details

510(k) Number K243036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2024
Decision Date June 15, 2025
Days to Decision 261 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
146d slower than avg
Panel avg: 115d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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
Candice Qiu

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 K243036.
Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF)
K251173 · Shenzhen Fansizhe Science And Technology Co., Ltd. · Jul 2025
Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK)
K250942 · Shenzhen Ulike Smart Electronics Co., Ltd. · Jul 2025
Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09)
K251000 · Shenzhen Chuangtong Yigou Technology Co., Ltd. · Jun 2025
IPL400
K250384 · El Global Trade, Ltd. · May 2025
Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK
K250938 · Shenzhen Ulike Smart Electronics Co., Ltd. · May 2025
IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10D)
K243017 · Foshan Newface Electronic Technology Co., Ltd. · May 2025