Cleared Traditional

K243017 - IPL Hair Removal Device (NV-TM10A

K243017 is an FDA 510(k) clearance for IPL Hair Removal Device (NV-TM10A, manufactured by Foshan Newface Electronic 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 221-day FDA review.

K243017 · Foshan Newface Electronic Technology Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
221d
Days
Class 2
Risk

K243017 is an FDA 510(k) clearance for the IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10D). Classified as Light Based Over-the-counter Hair Removal (product code OHT), Class II - Special Controls.

Submitted by Foshan Newface Electronic Technology Co., Ltd. (Foshan, CN). The FDA issued a Cleared decision on May 6, 2025 after a review of 221 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 Foshan Newface Electronic Technology Co., Ltd. devices

FDA 510(k) Submission Details - K243017

510(k) Number K243017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2024
Decision Date May 06, 2025
Days to Decision 221 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
106d slower than avg
Panel avg: 115d · This submission: 221d
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
Riley Chen

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 147
Devices cleared under the same product code (OHT) and FDA review panel - the closest regulatory comparables to K243017.
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 · Bestway Plastic and Metal Products , 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 (KCA511/KCA516/KCA522)
K250253 · Dongguan Boyuan Intelligent Technology Co.,Ltd · May 2025
Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)
K250194 · Shenzhen Ulike Smart Electronics Co., Ltd. · Mar 2025
IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023)
K250131 · Mustech Electronics Co., Limited · Mar 2025