ERCHONIA CORPORATION

FDA Device Registration & Listing · Fountain Inn, SC, US · Registration 2032513

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2032513
FEI Number
3003462036
Entity Name
ERCHONIA CORPORATION
City/State/Country
Fountain Inn, SC, US
Establishment Address
112 Southchase Blvd, Fountain Inn, SC 29644, US
Establishment Type(s)
Remanufacture Medical Device,Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
ERCHONIA CORPORATION (Owner Number: 9047254)
Owner / Operator Contact Address
112 Southchase Blvd, --, Fountain Inn, SC 29644, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K221987
PMA Number
N/A

All Registered Proprietary Names

Erchonia CLX Erchonia CLX-Reman VLS; VLS-RM XLR8; XLR8-RM PL Series (stand-alone or included in BST Erchonia Zerona VZ8-Reman Erchonia Zerona VZ8 Verju: Verju-RM VP3; VP3-RM; Percussor VA3; VA3-RM; Adjustor PL Touch: PL Touch-RM EML, EML-RM EVRL-RM EVRL Emerald-Reman; Emerald-RM; SHL-RM Emerald; SHL Erchonia XLR8 ; Erchonia XLR8 - Reman ; Erchonia HLS2 ; Erchonia HLS2-RM Erchonia FX-405 ; Erchonia FX-405 Reman ; Erchonia MLS-AC ; Erchonia MLS-AC RM Erchonia EVRL-OTC Erchonia EVRL-OTC-Reman, EVRL-OTC-RM Zerona Z6; Zerona Z6-Reman; Z6; Z6-RM; SHR; SHR-RM FX635; FX635-RM HPS; HPS-RM MLS, MLS-RM PL5, PL5-RM Erchonia GVL ; Erchonia GVL-Reman ; GVL-RM

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OLI Fat Reducing Low Level Laser General, Plastic Surgery Class 2 878.5400 2026-05-12
NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy Physical Medicine Class 2 890.5500 2014-03-20
NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy Physical Medicine Class 2 890.5500 2002-02-28
OLI Fat Reducing Low Level Laser General, Plastic Surgery Class 2 878.5400 2025-02-10
LYG Massager, Therapeutic, Manual Physical Medicine Class 1 890.5660 2013-10-31
OLI Fat Reducing Low Level Laser General, Plastic Surgery Class 2 878.5400 2013-10-31
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2011-12-07
NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy Physical Medicine Class 2 890.5500 2016-07-26
NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy Physical Medicine Class 2 890.5500 2008-06-16
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2019-09-06
NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy Physical Medicine Class 2 890.5500 2019-09-06
OLI Fat Reducing Low Level Laser General, Plastic Surgery Class 2 878.5400 2020-01-14
NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy Physical Medicine Class 2 890.5500 2021-12-08
NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy Physical Medicine Class 2 890.5500 2021-11-29
OLP Over-The-Counter Powered Light Based Laser For Acne General, Plastic Surgery Class 2 878.4810 2025-11-19
OLI Fat Reducing Low Level Laser General, Plastic Surgery Class 2 878.5400 2018-06-22
NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy Physical Medicine Class 2 890.5500 2019-09-06
OLI Fat Reducing Low Level Laser General, Plastic Surgery Class 2 878.5400 2013-10-31
NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy Physical Medicine Class 2 890.5500 2013-10-31
NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy Physical Medicine Class 2 890.5500 2022-10-12

Official Correspondent

Rebecca Tucek

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ERCHONIA CORPORATION
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K083258 Dornier Medtech America, Inc. MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE 2009-01-30
K201111 Candela Corporation GentleMax Pro Plus 2020-05-26
K202758 Shangdong Huamei Technology Co., Ltd. Nd: YAG Laser Therapy Systems HM-YL900 2020-11-16
K904068 Luxar Corp. LUXAR MODEL LX-20 CO2 LASER 1991-04-15
K142225 CAO Group, Inc. Pilot Elite Diode Laser 2014-09-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007 Lumenis Inc. 2
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2032513. Last updated year: 2026. Please use registration number 2032513 when referencing this establishment in official correspondence.
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