Cleared Traditional

K242382 - décoLITE LED Device (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K242382 · iSMART Developments, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2024
Decision
88d
Days
Class 2
Risk

K242382 is an FDA 510(k) clearance for the décoLITE LED Device. 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 November 8, 2024 after a review of 88 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 K242382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2024
Decision Date November 08, 2024
Days to Decision 88 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
26d faster than avg
Panel avg: 114d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT06542341 Completed Interventional Industry-sponsored

Study to Evaluate the Efficacy of the décoLITE LED Device in Treating the Signs of Skin Aging of the décolletage Area

18
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Wrinkle
Study design Single group
Eligibility All sexes · 30 Years+ · Healthy volunteers accepted
Sponsor Steven Baker (industry)
Started 2020-09-24 → Primary completion 2020-12-04 → Completed 2021-01-31
Primary outcome
Reduction in chest lines at rest
Secondary outcome
Reduction in chest pigmentation
Study completed - no results published. This trial concluded in 2021 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - OHS Light Based Over The Counter Wrinkle Reduction

All 148
Devices cleared under the same product code (OHS) and FDA review panel - the closest regulatory comparables to K242382.
LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)
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K254079 · Shenzhen Desida Technology Co., Ltd. · Mar 2026
Ulike Reglow Light Therapy Device (UM10)
K260511 · Shenzhen Ulike Smart Electronics Co., Ltd. · Mar 2026
LED Therapy Light (COB1400, HP1800PRO)
K253874 · Shenzhen Hanhua Opto Co., Ltd. · Mar 2026
FAQ™ (LED Panel)
K253683 · Foreo, Inc. · Feb 2026