Energy-Based Medical Devices Cleared and Approved, 2023–2026

Energy-based medical devices cleared and approved in the last few years: a regulatory overview (2023 to 2026)

Energy-based devices (EBDs) deliver a controlled physical energy, radiofrequency (RF), laser, intense pulsed light (IPL), ultrasound, microwave, cryogenic cooling, or pulsed electric fields, to heat, cool, ablate, coagulate, or otherwise modify tissue. They span consumer dermatology, aesthetic medicine, surgical energy, and high-risk interventional cardiology. This overview summarizes what has reached the US market through FDA's 510(k), De Novo, and Premarket Approval (PMA) pathways from January 2023 through mid-2026, organized by modality, with representative clearances a regulatory reviewer would recognize.

What the recent market looks like

Two patterns dominate the 2023 to 2026 window. First, pulsed field ablation (PFA) went from a novel concept to a crowded, PMA-approved cardiac category, with six distinct systems from the major electrophysiology manufacturers. Second, the aesthetic and dermatologic 510(k) space (RF skin tightening, RF microneedling, lasers, and IPL hair removal) continues to clear at high volume, increasingly driven by East Asian manufacturers and consumer home-use IPL devices.

Pulsed field ablation (PFA): the marquee cardiac category

PFA uses irreversible electroporation, non-thermal pulsed electric fields, to ablate cardiac tissue for atrial fibrillation, with the appeal of relative tissue selectivity versus thermal RF or cryo. All approved systems share product code QZI (percutaneous cardiac ablation catheter for AF with irreversible electroporation) and came through PMA:

Medtronic's PulseSelect was the first-of-category PMA in this window ⁶²⁶, followed by a rapid succession of competitor approvals, making PFA the defining energy-based device story of the period ^{632630631633628}.

Other cardiac ablation energy (RF, cryo, robotic)

Thermal and robotic cardiac ablation platforms continued to reach approval alongside PFA:

• TactiFlex Ablation Catheter, Sensor Enabled (RF, contact-force sensing), Abbott Medical, P220013, approved 2023-05-18 ⁶³⁵.
• POLARx / POLARx FIT Cryoablation Catheters with SMARTFREEZE console (cryogenic AF ablation), Boston Scientific, P220032, approved 2023-08-08 ⁶⁴⁰.
• INTELLAGEN Cardiac Ablation System (RF), Boston Scientific, approved 2024-07-17 across PMA files P920047/P150005/P020025 ^637638639.
• MAGiC Ablation Catheter (magnetically navigated RF), Stereotaxis, P240014, approved 2026-01-05 ⁶³⁴.

Renal denervation (ultrasound and the return of an energy category)

• Paradise Ultrasound Renal Denervation System (ablation catheter, renal denervation), ReCor Medical, P220023, approved 2023-11-07 ⁶⁴³. This marked FDA approval of catheter-based ultrasound renal denervation for hypertension, a device category that had spent years in clinical limbo.

Radiofrequency (RF) aesthetic and dermatologic devices

RF skin-tightening and RF microneedling devices cleared steadily under product code GEI (mostly 510(k)), dominated by aesthetic OEMs from South Korea, China, and established aesthetic players:

• The InMode System with Morpheus8 applicators (RF microneedling), InMode, K231790, cleared 2023-07-20 ²¹⁷.
• BTL-785X, BTL Industries, K222556, cleared 2023-05-31 ²¹².
• Volnewmer, Classys, K240248, cleared 2024-04-29 ²⁰⁷.
• POTENZA (RF microneedling), Jeisys Medical, K231216, cleared 2024-12-10 ²¹¹.
• Sunny, ShenB, K242241, cleared 2025-03-19 ²⁰⁶.
• NEW DOUBLO 2.0, Hironic, K251334, cleared 2025-09-29 ²¹⁵.
• InbellaMulti System, Inbella Medical, K252367, cleared 2025-10-15 ²¹⁶.

Lasers (aesthetic, surgical, and therapeutic)

Laser clearances were the highest-volume conventional EBD category, spanning dermatologic (GEX), surgical (GEX/NVK), and specialized neurosurgical laser interstitial thermal therapy (ONO):

• Exablate (see focused ultrasound) aside, notable laser 510(k)s include the JOULE 1064nm System, Sciton, K251077, cleared 2025-12-19 ¹¹¹.
• Vydence Family of Lasers, Vydence Medical, K252753, cleared 2026-01-24 ¹¹².
• MOSES Raydar (holmium laser lithotripsy/surgical), Boston Scientific, K260100, cleared 2026-05-18 ⁹⁷.
• SOGA Lasers therapy system / dental diode laser, Shenzhen Soga, K253309, cleared 2026-05-19 ⁷⁹.
• Visualase Cooled Laser Applicator System (MRI-guided laser interstitial thermal therapy, LITT), Medtronic Navigation, K253391, cleared 2026-03-13 ⁵⁷.

Intense pulsed light (IPL)

IPL clearances are heavily weighted toward consumer home-use hair removal (product code OHT) and, separately, IPL therapy devices (ONF), with a striking concentration of Chinese manufacturers plus mainstream consumer brands:

• Philips Lumea IPL (home-use hair removal), Philips Consumer Lifestyle, K253754, cleared 2025-12-23 ¹⁸⁰.
• Intense Pulsed Light Therapy Device, Sanhe LEFIS Electronics, K261204, cleared 2026-06-12 ¹¹⁵.

Focused ultrasound, HIFU, and histotripsy

This modality now includes conventional high-intensity focused ultrasound (HIFU), microfocused ultrasound for aesthetics, and non-thermal histotripsy:

• Exablate (MR-guided focused ultrasound, prostate), Insightec, K231378, cleared 2023-10-30 ²⁴⁹.
• SofWave System (microfocused ultrasound, aesthetic), Sofwave Medical, cleared repeatedly across 2023 to 2025, including K250146 on 2025-04-18 ²⁴⁸.
• Focal One (HIFU, prostate tissue ablation), EDAP Technomed, K251910, cleared 2025-11-19 ²⁴⁶.
• Edison System (histotripsy for liver tissue destruction), HistoSonics, De Novo DEN220087, granted 2023-10-06 ²⁴¹, establishing a new device classification for non-thermal focused-ultrasound tissue destruction.
• Neurolyser XR (focused ultrasound for facet-joint denervation of chronic back pain), Fusmobile, De Novo DEN250015, granted 2025-11-14 ²⁴³.

Microwave ablation

Microwave ablation systems for soft-tissue/tumor ablation (product code NEY) cleared consistently, led by established platforms and new entrants:

• NEUWAVE Microwave Ablation System, NeuWave Medical, K231738, cleared 2023-11-16 ²¹⁸.
• Emprint Ablation System with Thermosphere Technology, Medtronic, K233838, cleared 2024-03-28 ²³⁰.
• IntelliBlate Microwave Ablation System, Varian Medical Systems, K240480, cleared 2024-07-19 ²²⁷.
• swiftPro System (microwave, dermatologic/lesion treatment), Emblation, K250718, cleared 2025-08-08 ²³⁴.

Electrosurgical and ultrasonic surgical energy

Advanced bipolar vessel sealing, ultrasonic dissection, and integrated surgical energy platforms remained active under product code GEI and related codes:

• The ETHICON Total Energy System, Ethicon Endo-Surgery (Johnson & Johnson), K243067, cleared 2025-01-17 ⁶⁰⁵.
• THUNDERBEAT II Shears / Ultrasonic Bipolar Generator, Olympus, K252150, cleared 2025-10-07 ⁶⁰¹.
• CUSA Clarity Ultrasonic Surgical Aspirator System, Integra LifeSciences, K251162, cleared 2025-10-08 ⁶⁰⁶.
• Voyant Electrosurgical Generator, Applied Medical Resources, K252412, cleared 2025-10-31 ⁵⁹⁹.
• da Vinci SP Surgical System with da Vinci E-200 Generator (robotic electrosurgical energy), Intuitive Surgical, K253556, cleared 2026-01-16 ⁶⁰².

Cryolipolysis and cryotherapy

The controlled-cooling aesthetic space was quieter in this window; a representative recent clearance is:

• Cryo Sport 2.0 (cryotherapy/cryolipolysis, product code IRP), Avanutri, K252396, cleared 2026-05-29 ³.

Cryogenic energy also appears in cardiac ablation via the POLARx cryoablation platform noted above ⁶⁴⁰.

Regulatory pathway patterns worth noting

• Novel, first-of-category energy mechanisms tend to enter via De Novo (histotripsy, DEN220087 ²⁴¹; focused-ultrasound facet denervation, DEN250015 ²⁴³) and then create a predicate class for follow-on 510(k)s.
• High-risk interventional cardiology energy devices (PFA, RF, cryo, renal denervation) run through PMA, reflecting Class III risk and clinical-endpoint expectations ^626633643.
• The large-volume aesthetic and consumer segment (RF, laser, IPL) is a 510(k)-driven, substantial-equivalence market with a growing share of applicants based in China and South Korea ^215206180.

Limitations and suggested follow-ups

This overview is representative, not a complete census. It reflects FDA records only (no EU MDR/CE, UK, or other jurisdictions), and the aesthetic 510(k) categories in particular contain far more clearances than are listed here. Cardiac "ablation" keyword searches are noisy, so some genuine energy devices may sit outside the examples chosen. A regulatory team could usefully ask Rhizome for: (1) a complete product-code-scoped 510(k) census for a specific modality (e.g., all GEI RF clearances 2024 to 2026), (2) the predicate tree behind a given device, (3) MAUDE adverse-event signal for a specific EBD platform, or (4) the CE-marking/EU MDR status of any device above.