510(k) Report

FDA applicant

Jeisys Medical, Inc.

Seoul, KR19 decisions2008–20260 recalls

FDA records 19 decisions for Jeisys Medical, Inc. (Seoul, KR) from 2008 to 2026: 19 510(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 179 days from receipt to decision, against 113 for FDA’s reviews in the same codes and years. Its devices cite 19 predicates, 10 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Jeisys Medical Incorporated”.

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

FDA decisions per year

2in 2025

2008: 22010: 12015: 22016: 22019: 12020: 22021: 12022: 12023: 22024: 22025: 22026 (partial year): 1
2008high 2 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Jeisys Medical, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Jeisys Medical, 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?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories9decisions
  • GEXPowered Laser Surgical Instrument6decisions
  • ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect1decision
  • ILYLamp, Infrared, Therapeutic Heating1decision
  • OUHSkin Resurfacing Rf Applicator1decision
  • OHVFocused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption1decision

How long do its 510(k) reviews take?

Since 2016, its 13 510(k)s took a median of 179 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 113 days; 2 of its 13 were faster than that.

Whose devices does it build on?

Its devices cite 19 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 25 times; 10 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.

  • K192545PotenzaJeisys Medical Incorporated · 20206cite it
  • K201685PotenzaJeisys Medical, Inc. · 20214cite it
  • K153727INTRAcel Premium Fractional RF Micro Needle (FRM) SystemJeisys Medical, Inc. · 20163cite it
  • K162169EdgeOne CO2 LaserJeisys Medical, Inc. · 20163cite it
  • K230663DensityJeisys Medical, Inc. · 20232cite it
  • K231216PotenzaJeisys Medical, Inc. · 20242cite it

What has FDA decided for it lately?

  • K254185Potenza PrimeJeisys Medical Incorporated · 2026
  • K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated · 2025
  • K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated · 2025
  • K231216PotenzaJeisys Medical, Inc. · 2024
  • K231287PotenzaJeisys Medical, Inc. · 2024
  • K230663DensityJeisys Medical, Inc. · 2023
  • K223685SmoothCool HR SystemJeisys Medical, Inc. · 2023
  • K213484SmoothCool HR SystemJeisys Medical, Inc. · 2022

All 15 as Jeisys Medical, Inc. →All 4 as Jeisys Medical Incorporated →