510(k) Report

FDA applicant

Lutronic Corporation

North Reading, MA29 decisions2007–20253 recalls

FDA records 29 decisions for Lutronic Corporation (North Reading, MA) from 2007 to 2025: 29 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and GEI (Electrosurgical, Cutting & Coagulation &…). Since 2016 its 510(k)s took a median of 190 days from receipt to decision, against 97 for FDA’s reviews in the same codes and years. Its devices cite 54 predicates, 13 of them its own earlier devices. 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Lutronic Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2007: 22008: 42009: 22010: 12011: 22012: 42013: 22014: 12016: 12017: 22018: 22019: 12021: 12022: 22025: 2
2007high 4 (2008) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

2in 2026

2025: 12026 (partial year): 2
2007high 2 (2026) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Lutronic Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Lutronic Corporation’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument20decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories3decisions
  • ONGPowered Laser Surgical Instrument With MicrobeamFractional Output2decisions
  • NGXStimulator, Muscle, Powered, For Muscle Conditioning1decision
  • HQFLaser, Ophthalmic1decision
  • PDZLasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis1decision

Also: ILY (1).

How long do its 510(k) reviews take?

Since 2016, its 11 510(k)s took a median of 190 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 97 days; 4 of its 11 were faster than that.

Whose devices does it build on?

Its devices cite 54 predicates; 13 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 59 times; 13 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K113588Spectra Laser SystemLutronic Corporation · 20129cite it
  • K121481Infini Radiofrequency SystemLutronic Corporation · 20139cite it
  • K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation · 20225cite it
  • K080496Mosaic ECO2 Laser SystemLutronic Corporation · 20084cite it
  • K171009LASEMD Laser SystemLutronic Corporation · 20174cite it
  • K130199Clarity LPC Laser SystemLutronic Corporation · 20133cite it

What has FDA decided for it lately?

  • K251327XERFLutronic Corporation · 20251 recall
  • K244060eCO2 3DLutronic Corporation · 2025
  • K213748CoreLeveeLutronic Corporation · 2022
  • K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation · 2022
  • K203788DermaV Laser SystemLutronic Corporation · 20211 recall
  • K183566CLARITY II Laser SystemLutronic Corporation · 20191 recall
  • K180945LUTRONIC GENIUS Radiofrequency SystemLutronic Corporation · 2018
  • K173700PICOPLUS Laser SystemLutronic Corporation · 2018

All 29 as Lutronic Corporation →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K203788Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that…Aug 6, 2026Class II
  • K183566CLARITY II Laser System; Model No. 1110200210.Jan 27, 2026Class II
  • K251327XERF EFFECTOR 60. Electrosurgical unit.Sep 4, 2025Class II

Other applicant names beginning “Lutronic”

FDA records each applicant name separately; these may or may not be the same firm.

Lutronic Vision, Inc. 1Lutronic Global 1Lutronic Aesthetic 1