K221987 is an FDA 510(k) clearance for the Erchonia GVL. Classified as Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy (product code NHN), Class II - Special Controls.
Submitted by Erchonia Corporation (Melbourne, US). The FDA issued a Cleared decision on September 1, 2022 after a review of 57 days - a notably fast clearance cycle.
This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 890.5500 - 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 Erchonia Corporation devices
NCT00929305
Completed
Interventional
Industry-sponsored
Low Level Laser Light Therapy and Chronic Neck and Shoulder Pain
Study of the Effect of Low Level Laser Therapy on the Reduction of Chronic Pain Associated With Neck and Shoulder Pain of Musculoskeletal Origin.
| Condition studied |
Shoulder Pain; Neck Pain; Musculoskeletal Pain; Musculoskeletal Strain; Musculoskeletal Sprain |
| Study design |
Parallel |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
Gregory C Roche, DO |
| Sponsor |
Erchonia Corporation
(industry)
|
Started 2001-01-01
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Primary completion 2001-06-01
Primary outcome
The Number of Participants Whose Self-reported Pain Rating in the Neck and Shoulder Area on the 0-100 Visual Analog Scale (VAS) Decreased by 30% or More From Baseline to One Day After Study Treatment
Secondary outcome
Range of Motion of the Neck and Shoulders
View full study on ClinicalTrials.gov