Cleared Traditional

K191629 - faceLITE

K191629 is the FDA 510(k) clearance for faceLITE by Ismart Marketing Svcs, Ltd.. It is a Class 2 General & Plastic Surgery device (product code OHS) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K191629 · Ismart Marketing Svcs, Ltd. · General & Plastic Surgery device
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Sep 2019
Decision
85d
Days
Class 2
Risk

K191629 is an FDA 510(k) clearance for the faceLITE. Classified as Light Based Over The Counter Wrinkle Reduction (product code OHS), Class II - Special Controls.

Submitted by Ismart Marketing Svcs, Ltd. (Birmingham, GB). The FDA issued a Cleared decision on September 12, 2019 after a review of 85 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.

View all Ismart Marketing Svcs, Ltd. devices

Submission Details

510(k) Number K191629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2019
Decision Date September 12, 2019
Days to Decision 85 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
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - OHS Light Based Over The Counter Wrinkle Reduction

All 119
Devices cleared under the same product code (OHS) and FDA review panel - the closest regulatory comparables to K191629.
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