510(k) Report

FDA applicant

Sciton, Inc

Palo Alto, CA23 decisions2000–20250 recalls

FDA records 23 decisions for Sciton, Inc (Palo Alto, CA) from 2000 to 2025: 23 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and PDZ (Lasers For Temporary Increase Of Clear Nail In…). Since 2016 its 510(k)s took a median of 208 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 117 predicates, 23 of them its own earlier devices. No recall is 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 Sciton, Inc’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007: 12008: 12011: 22013: 12018: 22019: 12022: 22024: 12025: 1
2007high 2 (2011) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sciton, 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 Instrument21decisions
  • PDZLasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis1decision
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 208 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 0 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 117 predicates; 23 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 67 times; 23 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.

  • K032460Profile BBL SystemSciton, Inc · 200310cite it
  • K060033Profile Multi-Platform SystemSciton, Inc · 20069cite it
  • K070388Profile Multi-Platform SystemSciton, Inc · 20078cite it
  • K040005Profile 2000/3000 Laser SystemSciton, Inc · 20046cite it
  • K101916Joule Multi-Platform SystemSciton, Inc · 20116cite it
  • K023881Profile 1064 Laser SystemSciton, Inc · 20035cite it

What has FDA decided for it lately?

  • K251077JOULE 1064nm System and AccessoriesSciton, Inc · 2025
  • K222958mJOULE RF System and AccessoriesSciton, Inc · 2024
  • K213761Joule diVa SystemSciton, Inc · 2022
  • K213350mJOULE System and AccessoriesSciton, Inc · 2022
  • K182173Joule SystemSciton, Inc · 2019
  • K180508Joule SystemSciton, Inc · 2018
  • K173285Joule SystemSciton, Inc · 2018
  • K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc · 2013

All 23 as Sciton, Inc →