Erchonia Corporation: FDA filings under this applicant name

FDA lists 26 510(k) clearances under the applicant name “Erchonia Corporation” (first 2010, latest 2026), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 88 days. Since 2017 the median was 88 days, against 121 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Erchonia Corporation took a median 88 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 121 days.

Top product codes

Review panels

• General and Plastic Surgery (14)
• Physical Medicine (12)

Most recent Erchonia Corporation 510(k) clearances

16 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named Erchonia Corporation.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Device clinical trials

An industry sponsor named Erchonia Corporation is the lead sponsor of 35 device studies on ClinicalTrials.gov (4 active or recruiting). Most recent:

• NCT07600203: A Double-blind, Placebo-controlled Evaluation of the Effect of the Erchonia® EVRL on Chronic Jaw Pain Arising From TMJ (Recruiting, started 2026-05-14)
• NCT06941610: An Evaluation of the Erchonia Laser As a Non-Invasive Treatment to Improve the Appearance of Skin Laxity (Recruiting, started 2025-05-30)
• NCT06912646: Clinical Efficacy of the Erchonia EVRL for Providing Temporary Relief of Idiopathic Peripheral Neuropathy Foot Pain (Recruiting, started 2025-05-01)
• NCT06656325: An Evaluation of the Effect of the Erchonia FX-405 Laser as an Adjunctive Treatment of Periodontitis (Recruiting, started 2025-01-01)
• NCT05954065: An Evaluation of the Effect of the Erchonia Laser for Non-invasive Reduction of Submental Fat (Completed, started 2023-07-12)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Erchonia Medical, Inc. (10 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Erchonia Corporation?

FDA lists 26 510(k) clearances under the applicant name “Erchonia Corporation” (first 2010, latest 2026), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Erchonia Corporation?

The median time from FDA receipt to decision across 510(k)s cleared under the name Erchonia Corporation is 88 days. Since 2017: 88 days, versus 121 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Erchonia Corporation?

The most frequent FDA product codes under this applicant name are OLI (Fat Reducing Low Level Laser, 13); NHN (Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy, 12); OLP (Over-The-Counter Powered Light Based Laser For Acne, 1).

Next steps

• See all 26 Erchonia Corporation clearances with predicates and recalls
• Run predicate analysis for product code OLI, Erchonia Corporation's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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