Cleared Traditional

LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) (K231555) - FDA 510(k) Clearance

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

K231555 · iSMART Developments, Ltd. · General & Plastic Surgery device
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Jul 2023
Decision
58d
Days
Class 2
Risk

K231555 is an FDA 510(k) clearance for the LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)). Classified as Light Based Over The Counter Wrinkle Reduction (product code OHS), Class II - Special Controls.

Submitted by iSMART Developments, Ltd. (Birmingham, GB). The FDA issued a Cleared decision on July 27, 2023 after a review of 58 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 Developments, Ltd. devices

Submission Details

510(k) Number K231555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2023
Decision Date July 27, 2023
Days to Decision 58 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
57d faster than avg
Panel avg: 115d · This submission: 58d
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 117
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