Cleared Traditional

K262752 - Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9)

K262752 is an FDA 510(k) clearance for Facial Therapy Mask (Z1, manufactured by Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code OHS cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K262752 · Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
81d
Days
Class 2
Risk

K262752 is an FDA 510(k) clearance for the Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9). Classified as Light Based Over The Counter Wrinkle Reduction (product code OHS), Class II - Special Controls.

Submitted by Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 23, 2026 after a review of 81 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.

FDA 510(k) Submission Details - K262752

510(k) Number K262752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2026
Decision Date October 23, 2026
Days to Decision 81 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
34d faster than avg
Panel avg: 115d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OHS Device Classification - Class 2, Special Controls

Product Code OHS Light Based Over The Counter Wrinkle Reduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition Use Of Light Based Treatment To Reduce Wrinkles On The Body In General Or Specific Anatomical Locations Depending On The Information Provided.
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

Flying Drug & Medical Compliance Service Co., Ltd.
Qin 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 - OHS Light Based Over The Counter Wrinkle Reduction

All 163
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K262752 · Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9)
Download PDF FDA Summary Shenzhen Xinlong Prec…