K150212 is an FDA 510(k) clearance for the DeScribe Transparent PFD Patch. Classified as Transparent Patch For Use In Treatment Of Tattoos (product code PKO), Class II - Special Controls.
Submitted by On Light Sciences, Inc. (Dublin, US). The FDA issued a Cleared decision on April 20, 2015 after a review of 80 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.
NCT02297321
Completed
Interventional
Industry-sponsored
Evaluation of the Safety and Efficacy of the DeScribe™ Patch
Evaluation of the Safety and Efficacy of the DeScribe™ Laser Tattoo Removal Accessory Device
| Condition studied |
Tattoos |
| Study design |
Single group |
| Eligibility |
All sexes
· 18 Years+
· Healthy volunteers accepted
|
| Principal investigator |
Brian Biesman, MD |
| Sponsor |
ON Light Sciences
(industry)
|
Started 2014-11-01
→
Primary completion 2015-01-01
→
Completed 2015-04-01
Primary outcome
Number of passes with Describe patch
Secondary outcome
Safety assessment: Overall rate and severity of all reported adverse events
Study completed - no results published.
This trial concluded in 2015 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510(k) Summary PDF or remain unpublished.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