FDA Registration
Active
🇺🇸 United States
ERCHONIA CORPORATION
Reg #: 2032513
·
FEI: 3003462036
·
Expires 2026
Products
7
Proprietary Names
29
Establishment Types
3
Classifications
7
Registration Details
- Registration Name
- ERCHONIA CORPORATION
- Registration Number
- 2032513
- FEI Number
- 3003462036
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 112 Southchase Blvd
- City
- Fountain Inn
- State
- SC
- ZIP
- 29644
- Country
- US
Regulatory Submissions
- 510(k) Number
- K252574
Owner / Operator
- Firm Name
- ERCHONIA CORPORATION
- Operator Number
- 9047254
- Address
- 112 Southchase Blvd, --
- City
- Fountain Inn
- State
- SC
- Postal Code
- 29644
- Country
- US
- Correspondent
- Rebecca Tucek
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fat Reducing Low Level Laser | OLI | Class 2 | General, Plastic Surgery | No | 2026-05-12 |
| Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy | NHN | Class 2 | Physical Medicine | No | 2014-03-20 |
| Massager, Therapeutic, Manual | LYG | Class 1 | Physical Medicine | No | 2013-10-31 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2011-12-07 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2019-09-06 |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | Class 2 | General, Plastic Surgery | No | 2025-11-19 |
| Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | PDZ | Class 2 | General, Plastic Surgery | No | 2016-06-22 |
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
Zerona-AD; Zerona-AD-RM
Verju (Formerly Zerona 2)
FFS; FFS-RM; Lunula; LunulaLaser
Establishment Types
Remanufacture Medical Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device