510(k) Report

FDA applicant

Cutera, Inc.

Brisbane, CA31 decisions2004–20252 recalls

FDA records 31 decisions for Cutera, Inc. (Brisbane, CA) from 2004 to 2025: 31 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and PBX (Massager, Vacuum, Radio Frequency Induced Heat). Since 2016 its 510(k)s took a median of 79 days from receipt to decision, against 102 for FDA’s reviews in the same codes and years. Its devices cite 66 predicates, 20 of them its own earlier devices. 2 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 Cutera, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007: 22008: 22009: 12011: 22012: 12013: 22014: 32016: 32017: 32018: 22022: 32023: 22025: 1
2007high 3 (2014) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

1in 2013

2010: 12013: 1
2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

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

See the 510(k) Report

Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument20decisions
  • PBXMassager, Vacuum, Radio Frequency Induced Heat5decisions
  • NUVMassager, Vacuum, Light Induced Heating2decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories2decisions
  • PDZLasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis1decision
  • ILYLamp, Infrared, Therapeutic Heating1decision

How long do its 510(k) reviews take?

Since 2016, its 14 510(k)s took a median of 79 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 102 days; 11 of its 14 were faster than that.

Whose devices does it build on?

Its devices cite 66 predicates; 20 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 61 times; 20 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.

  • K103626Cutera Genesisplus Laser SystemCutera, Inc. · 20117cite it
  • K153671Family of CoolGlide Aesthetic LasersCutera, Inc. · 20166cite it
  • K050047Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc. · 20055cite it
  • K133739TrusculptCutera, Inc. · 20145cite it
  • K042165Cutera Tabletop Aesthetic ProductCutera, Inc. · 20044cite it
  • K122493GenesisplusCutera, Inc. · 20133cite it

What has FDA decided for it lately?

  • K251149AviClear Laser SystemCutera, Inc. · 2025
  • K233237xeo+ FamilyCutera, Inc. · 2023
  • K230660AviClear Laser SystemCutera, Inc. · 2023
  • K223110truSculpt iDCutera, Inc. · 2022
  • K221407truSculpt iDCutera, Inc. · 2022
  • K213461AviClear Laser SystemCutera, Inc. · 2022
  • K182997enlighten III Laser SystemCutera, Inc. · 2018
  • K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc. · 2018

All 31 as Cutera, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K122389Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency…Oct 16, 2013Class II
  • K042165Titan XL Handpiece Infrared Therapeutic Heating Lamp, Manufactured by Cutera Inc…May 8, 2010