Cleared Traditional

K213056 - LED Facial Mask (FDA 510(k) Clearance)

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

K213056 · Shenzhen Osto Technology Company Limited · General & Plastic Surgery device
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Jul 2022
Decision
288d
Days
Class 2
Risk

K213056 is an FDA 510(k) clearance for the LED Facial Mask. Classified as Over-the-counter Powered Light Based Laser For Acne (product code OLP), Class II - Special Controls.

Submitted by Shenzhen Osto Technology Company Limited (Shenzhen, CN). The FDA issued a Cleared decision on July 7, 2022 after a review of 288 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 Osto Technology Company Limited devices

Submission Details

510(k) Number K213056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2021
Decision Date July 07, 2022
Days to Decision 288 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
174d slower than avg
Panel avg: 114d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OLP Over-the-counter Powered Light Based Laser For Acne
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition The Device Is Intended For Over-the-counter (otc) Use To Treat Patients With Mild To Moderate Acne Vulgaris. The Device Is Intended To Emit Energy In The Red And Blue Region Of The Spectrum, Specifically Indicated To Treat Mild To Moderate Acne Vulgaris.
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

Guangdong Jianda Medical Technology Co., Ltd.
Jett Lee

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 - OLP Over-the-counter Powered Light Based Laser For Acne

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