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Cardiogenes

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Devices
20

What Cardiogenes makes

Cardiogenes manufactures laser-based medical devices for tissue ablation and surgical procedures, including fiberoptic delivery systems and handheld probes for precise energy application. Their products include systems like the Eclipse series for general and urology-specific use, as well as photodynamic laser therapy (PLDT) kits for targeted tissue treatment. The company also produces the CrossFire system for controlled tissue modification and the PowerSculptor probes for sculpting or reshaping tissue.

The company’s devices are classified as Class II under FDA regulations and are authorised via the 510(k) clearance process. These products are listed in the FDA’s 510(k) registry, reflecting their compliance with US medical device standards. Cardiogenes operates as a US-based manufacturer.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue20

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  • Powersculptor Probes Ref K952755

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Eclipse Lazerblade(Tm) Fiberoptic Delivery System Ref K934935

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Eclipse 3200 Ref K945126

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Sunrise Technologies Model 5020 Pldd Kit Ref K944758

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Crossfire(Tm) (705-10650) Ref K943171

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Eclipse 2100 Ref K955006

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Eclipse 3200 For Use In Urology Applications Ref K931305

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Eclipse 3200 Ref K925840

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Eclipse 3200 Ref K926210

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Eclipse 3200 Ref K953424

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Eclipse 2000 Ref K961560

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Eclipse 2100(Tm) Model 32 Ref K924214

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Optical Fiber For Ent Applications Ref K944151

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Eclipse 3200 For Use In Ortho Surg/Arth Appl Joint Ref K931306

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Eclipse 3200 Ref K943311

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Eclipse 3200 Ref K944153

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Eclipse 2100 Ref K921038

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Eclipse 2100(Tm) Model 32, Modification Ref K931101

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Eclipse 3200(Tm) Ho:yag Laser For Percu Disketomy Ref K924943

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Corssfire Plus Ref K953658

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-20 of 20

Frequently asked questions

How many devices does Cardiogenes have in the registry?

The registry currently lists 20 devices for Cardiogenes. Devices recorded under merged duplicate company entries are counted once.

Which registries list Cardiogenes's devices?

Among its 20 most recently registered devices, Cardiogenes has devices listed in FDA 510(k) (20 devices).

What risk classes do Cardiogenes's devices fall under?

Among its 20 most recently registered devices, the classes recorded for Cardiogenes's devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Cardiogenes in the registry?

The most recently registered devices listed for Cardiogenes include POWERSCULPTOR PROBES, ECLIPSE LAZERBLADE(TM) FIBEROPTIC DELIVERY SYSTEM, ECLIPSE 3200 and SUNRISE TECHNOLOGIES MODEL 5020 PLDD KIT.

Generated automatically from registry data and not verified by a human reviewer.