K202848 is an FDA 510(k) clearance for the S2 Pigment Removal System. Classified as Powered Laser Surgical Instrument within the GEX classification (a category for powered laser surgical instruments across multiple specialties), Class II - Special Controls.
Submitted by Lightsense Technologies, Ltd. (London, GB). The FDA issued a Cleared decision on December 14, 2021 after a review of 445 days - an unusually long review period, suggesting complex equivalence evaluation.
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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.
View all Lightsense Technologies, Ltd. devices
NCT03866304
Unknown
Interventional
Industry-sponsored
Performance Evaluation of Tattoo Removal
A Single-center, Open-label, Uncontrolled Pilot Study to Evaluate the Safety and Efficacy of S2 - Multi-Wavelength Laser for Tattoo Removal
| Condition studied |
Tattoo Removal |
| Study design |
Single group |
| Eligibility |
All sexes
· 18 Years+
· Healthy volunteers accepted
|
| Principal investigator |
Ruta Ganceviciene,, Dr |
| Sponsor |
LigthSense Israel Ltd
(industry)
|
Started 2019-01-21
→
Primary completion 2019-08-31
Primary outcome
Tattoo clearing
Secondary outcome
Degree of tattoo clearing as assessed by PGA
View full study on ClinicalTrials.gov