Company ยท US
Lutronic Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2025. Name variants (Inc, Corp, punctuation) are merged.
29510(k) clearances (0 in 12 months)
3recalls (2 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEX | Powered Laser Surgical Instrument | 22 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 |
| ONG | Powered Laser Surgical Instrument With MicrobeamFractional Output | 2 |
| HQF | Laser, Ophthalmic | 1 |
| ILY | Lamp, Infrared, Therapeutic Heating | 1 |
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 1 |
| PDZ | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 11, 2025 | K251327 | XERF Lutronic Corporation, KR | GEI |
| Jul 31, 2025 | K244060 | eCO2 3D Lutronic Corporation, KR | ONG |
| Oct 14, 2022 | K213748 | CoreLevee Lutronic Corporation, KR | NGX |
| Feb 4, 2022 | K213569 | HOLLYWOOD SPECTRA Laser System Lutronic Corporation, KR | GEX |
| Mar 26, 2021 | K203788 | DermaV Laser System Lutronic Corporation, KR | GEX |
| Jun 14, 2019 | K183566 | CLARITY II Laser System Lutronic Corporation, KR | GEX |
| Dec 10, 2018 | K180945 | LUTRONIC GENIUS Radiofrequency System Lutronic Corporation, KR | GEI |
| Jun 19, 2018 | K173700 | PICOPLUS Laser System Lutronic Corporation, KR | GEX |
| Jun 23, 2017 | K171009 | LASEMD Laser System Lutronic Corporation, KR | GEX |
| May 24, 2017 | K163196 | ACTION II Laser System Lutronic Corporation, KR | GEX |
| Oct 5, 2016 | K153769 | R:GEN Laser System Lutronic Corporation, KR | HQF |
| Nov 6, 2014 | K141555 | ADVANTAGE Lutronic Corporation | GEX |
| Nov 22, 2013 | K130199 | CLARITY LPC LASER SYSTEM Lutronic Corporation | GEX |
| Jun 25, 2013 | K121481 | INFINI RADIOFREQUENCY SYSTEM Lutronic Corporation | GEI |
| Sep 27, 2012 | K113843 | FREEDOM ND: YAG LASER SYSTEM Lutronic Corporation | PDZ |
| Jun 19, 2012 | K113668 | HEALITE II SYSTEM Lutronic Corporation | ILY |
| Apr 5, 2012 | K113502 | ADVANTAGE LASER SYSTEM Lutronic Corporation | GEX |
| Feb 22, 2012 | K113588 | SPECTRA LASER SYSTEM Lutronic Corporation | GEX |
| Apr 28, 2011 | K103455 | SPECTRA LASER SYSTEM Lutronic Corporation | GEX |
| Jan 20, 2011 | K100610 | LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS Lutronic Corporation | ONG |
| Sep 23, 2010 | K101573 | ACCUSCULPT II LASER SYSTEM Lutronic Corporation | GEX |
| Oct 30, 2009 | K091115 | ECO2 LASER SYSTEM Lutronic Corporation | GEX |
| Aug 19, 2009 | K091320 | SPECTRA SP II, SPECTRA DENTA II Lutronic Corporation | GEX |
| Oct 8, 2008 | K082096 | POWERLIPO LASER SYSTEM Lutronic Corporation | GEX |
| Jul 7, 2008 | K080496 | MOSAIC ECO2 LASER SYSTEM Lutronic Corporation | GEX |
| Jun 9, 2008 | K080932 | MOSAIC LASER SYSTEM Lutronic Corporation | GEX |
| Apr 23, 2008 | K080248 | SPECTRA VRMIII Q-SWITCHED ND: YAG LASER SYSTEM AND DYE HANDPIECES Lutronic Corporation | GEX |
| Dec 28, 2007 | K073436 | SPECTRA VRMII 1-SWITCHED ND:YAG LASER SYSTEM Lutronic Corporation | GEX |
| Jul 13, 2007 | K070392 | MOSAIC LASER SYSTEM Lutronic Corporation | GEX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2026 | Lutronic Corporation Product Name: DermaV Laser System
Model/Catalog Number: DermaV
Medical laser device that delivers pulsed laser energy at wavelengths of 532 nm and 1064 nm through a fiber-optic handpiece. The system Open, Classified |
GEX | K203788 |
| Mar 12, 2026 | Lutronic Corporation CLARITY II Laser System; Model No. 1110200210. Open, Classified |
GEX | K183566 |
| Oct 14, 2025 | Lutronic Corporation XERF EFFECTOR 60. Electrosurgical unit. Open, Classified |
GEI | K251327 |