K212492 is an FDA 510(k) clearance for the Frax 1940 for Nordlys and Frax Pro. 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 Candela Corporation (Marlborough, US). The FDA issued a Cleared decision on December 20, 2021 after a review of 133 days - within the typical 510(k) review window.
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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.
View all Candela Corporation devices
NCT04203745
Completed
Interventional
Industry-sponsored
Nonablative Fractional Diode Laser for Treatment of Skin Resurfacing and Pigmented Lesions
Clinical Evaluation of a Nonablative Fractional 1940 nm Diode Laser for Skin Resurfacing and Treatment of Pigmented Lesions
| Condition studied |
Skin Texture; Pigmented Lesions |
| Study design |
Single group |
| Eligibility |
All sexes
· 21 Years+
· Healthy volunteers accepted
|
| Principal investigator |
Konika P Schallen, M.D. |
| Sponsor |
Candela Corporation
(industry)
|
Started 2019-09-18
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Primary completion 2021-04-30
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Completed 2021-08-05
Primary outcome
Pigmented Lesion Improvement by Blinded Evaluation
View full study on ClinicalTrials.gov