Lutronic Corporation
Lutronic Corporation holds FDA 510(k) medical device clearances, first cleared 2007, most recent 2025, with 3 FDA device recalls on record.
Top product codes for Lutronic Corporation
FDA recalls by Lutronic Corporation
- Z-3110-2026 — 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 may be configured with an Intelligent Cooling Device (ICD) to provide epidermal cooling during laser treatment
- Z-1558-2026 — CLARITY II Laser System; Model No. 1110200210.
- Z-0146-2026 — XERF EFFECTOR 60. Electrosurgical unit.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Lutronic Corporation
- K251327 — XERF
- K244060 — eCO2 3D
- K213748 — CoreLevee
- K213569 — HOLLYWOOD SPECTRA Laser System
- K203788 — DermaV Laser System
- K183566 — CLARITY II Laser System
- K180945 — LUTRONIC GENIUS Radiofrequency System
- K173700 — PICOPLUS Laser System
- K171009 — LASEMD Laser System
- K163196 — ACTION II Laser System
- K153769 — R:GEN Laser System
- K141555 — ADVANTAGE
- K130199 — CLARITY LPC LASER SYSTEM
- K121481 — INFINI RADIOFREQUENCY SYSTEM
- K113843 — FREEDOM ND: YAG LASER SYSTEM
- K113668 — HEALITE II SYSTEM
- K113502 — ADVANTAGE LASER SYSTEM
- K113588 — SPECTRA LASER SYSTEM
- K103455 — SPECTRA LASER SYSTEM
- K100610 — LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMS
- K101573 — ACCUSCULPT II LASER SYSTEM
- K091115 — ECO2 LASER SYSTEM
- K091320 — SPECTRA SP II, SPECTRA DENTA II
- K082096 — POWERLIPO LASER SYSTEM
- K080496 — MOSAIC ECO2 LASER SYSTEM
- K080932 — MOSAIC LASER SYSTEM
- K080248 — SPECTRA VRMIII Q-SWITCHED ND: YAG LASER SYSTEM AND DYE HANDPIECES
- K073436 — SPECTRA VRMII 1-SWITCHED ND:YAG LASER SYSTEM
- K070392 — MOSAIC LASER SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.