510(k) Report

FDA applicant

Classys, Inc.

Seoul, KR4 decisions2023–20260 recalls

FDA records 4 decisions for Classys, Inc. (Seoul, KR) from 2023 to 2026: 4 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and GEX (Powered Laser Surgical Instrument). Since 2016 its 510(k)s took a median of 173 days from receipt to decision, against 108 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 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 Classys, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2023: 12024: 12025: 12026 (partial year): 1
2023high 1 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Classys, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Classys, 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?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories2decisions
  • GEXPowered Laser Surgical Instrument1decision
  • OHVFocused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 173 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 108 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K240248Volnewmer™Classys, Inc. · 20241cites it

What has FDA decided for it lately?

  • K253504Volnewmer™Classys, Inc. · 2026
  • K253123CuRAS hybridClassys, Inc. · 2025
  • K240248Volnewmer™Classys, Inc. · 2024
  • K230100Scizer (SC1-M410)Classys, Inc. · 2023

All 4 as Classys, Inc. →