DENSITY; DENZA; DENSITY Noir

The DENSITY, DENZA, and DENSITY Noir devices are radiofrequency electrosurgical units operating at 6.78 MHz that deliver RF energy through handpiece electrodes to coagulate tissue and achieve hemostasis. They use a 'reverse thermal gradient' principle to selectively coagulate deeper tissue while cooling the epidermis, causing collagen denaturation and contraction. The devices are indicated for use in dermatologic and general surgical procedures.

The proposed devices match the predicate (K230663) in operating frequency (6.78 MHz), maximum power (400 W), temperature range (65–75°C), impedance (75–400 Ω), RF time (50–800 ms), coolant solution (cryogen 1234ze), electrode tip types (0.25, 4, and 16 cm²), and LCD touch-screen interface. The proposed device adds 7 new electrode tip designs (13 total versus 6 in predicate) and includes both monopolar and bipolar modes versus monopolar-only in the predicate, though these differences are attributed to film design variation without affecting performance or safety.

Devices were evaluated per IEC 60601-1:2005 and amendments for basic safety; IEC 60601-1-2:2014 for electromagnetic compatibility; IEC 60601-2-2 for high-frequency surgical equipment; IEC 60601-1-6:2013 for usability; IEC 62304:2006 for software lifecycle; IEC 62366:2008 for usability engineering; ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010 for biocompatibility; and ISO 14971:2019 for risk management. Ex vivo thermal testing was conducted on three tissue types per FDA's August 2014 guidance for electrosurgical devices.

The proposed devices are substantially equivalent because they share identical fundamental specifications with the predicate (same frequency, power, temperature, impedance, coolant, and core electrode tip sizes) and the same indication for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The seven additional electrode tip designs differ only in film design without changing performance or safety. The addition of bipolar capability alongside monopolar (versus monopolar-only in predicate) does not create new safety concerns. Non-clinical performance data—including biocompatibility, bench testing, and software validation—demonstrate the device operates within design specifications, and no differences between the subject and predicate devices adversely affect product use.