Cleared Traditional

K223882 - Narrowband UV Phototherapy Light Lamp (...

K223882 is an FDA 510(k) clearance for Narrowband UV Phototherapy Light Lamp (..., manufactured by Shenzhen Honpal Optoelectronic Technology Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code FTC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K223882 · Shenzhen Honpal Optoelectronic Technology Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2023
Decision
90d
Days
Class 2
Risk

K223882 is an FDA 510(k) clearance for the Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02). Classified as Light, Ultraviolet, Dermatological (product code FTC), Class II - Special Controls.

Submitted by Shenzhen Honpal Optoelectronic Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 27, 2023 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4630 - 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 Honpal Optoelectronic Technology Co., Ltd. devices

FDA 510(k) Submission Details - K223882

510(k) Number K223882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2022
Decision Date March 27, 2023
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTC Device Classification - Class 2, Special Controls

Product Code FTC Light, Ultraviolet, Dermatological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4630
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

Shanghai Truthful Information Technology Co., Ltd.
Boyle Wang

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 - FTC Light, Ultraviolet, Dermatological

All 51
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