510(k) Report

FDA applicant

Cynosure, Inc.

Wesford, MA107 decisions1992–20261 recall

FDA records 107 decisions for Cynosure, Inc. (Wesford, MA) from 1992 to 2026: 107 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and PKT (Laser For Disruption Of Adipocyte Cells For…). Since 2016 its 510(k)s took a median of 88 days from receipt to decision, against 95 for FDA’s reviews in the same codes and years. Its devices cite 69 predicates, 39 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Cynosure, LLC”, “Cynosure”.

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 Cynosure, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007: 42008: 42009: 62010: 12011: 12012: 42013: 22014: 62015: 42016: 22017: 32018: 22019: 22020: 22021: 12022: 22023: 12024: 12026 (partial year): 1
2007high 6 (2009) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Cynosure, Inc.’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 Instrument84decisions
  • PKTLaser For Disruption Of Adipocyte Cells For Aesthetic Use6decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories5decisions
  • ILYLamp, Infrared, Therapeutic Heating4decisions
  • OHSLight Based Over The Counter Wrinkle Reduction2decisions
  • OYWLaser, Cellulite Appearance2decisions

Also: ISA (1), PBX (1), GAT (1), FTC (1).

How long do its 510(k) reviews take?

Since 2016, its 14 510(k)s took a median of 88 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 95 days; 8 of its 14 were faster than that.

Whose devices does it build on?

Its devices cite 69 predicates; 39 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 197 times; 39 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.

  • K034030Apogee EliteCynosure, Inc. · 200414cite it
  • K121346Picosure WorkstationCynosure, Inc. · 201212cite it
  • K062321Smartlipo ND:Yag LaserCynosure, Inc. · 20068cite it
  • K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc. · 20148cite it
  • K992757Cynosure Apogee-TKS Dermatological LaserCynosure, Inc. · 20008cite it
  • K971737Cynosure Photogenica Lpir Dermatological LaserCynosure, Inc. · 19978cite it

What has FDA decided for it lately?

  • K261570Picosure WorkstationCynosure, LLC · 2026
  • K240396Elite iQ PRO (M122K1)Cynosure, LLC · 2024
  • K230510MyEllevateCynosure, LLC · 2023
  • K223292TempSure SystemCynosure, LLC · 2022
  • K212891TempSure SystemCynosure, LLC · 2022
  • K210226PicoSure WorkstationCynosure, LLC · 2021
  • K200241TempSure SystemCynosure, LLC · 2020
  • K193426Elite iQCynosure, LLC · 2020

All 98 as Cynosure, Inc. →All 8 as Cynosure, LLC →The one decision as Cynosure →

What has been recalled?

1 recall linked to its devices; the latest:

  • K091169Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser SystemOct 9, 2014Class II

Other applicant names beginning “Cynosure”

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

Cynosure, Inc. Dba Ellman 1Cynosure Lutronic Technology Corporation 1