Executive snapshot (2022–2025)

• The market saw a broad wave of energy-based device clearances across oncology, cardiovascular, GI endoscopy, spine/orthopedics, ENT, gynecology, vascular, neurosurgery, and aesthetics. The vast majority entered via FDA 510(k) as Class II devices based on substantial equivalence, not PMA or De Novo ^{23913178143284252}.
• Modalities most represented were microwave ablation and radiofrequency (RF), with several hybrid platforms (RF+microwave, RF+laser, RF+helium plasma). One nonthermal electrosurgical system using nanosecond Pulsed Field Ablation (nsPFA) for soft-tissue ablation also received 510(k) clearance ¹³¹.
• Most clearances were new iterations or line extensions, not first-of-a-kind devices; sponsors emphasized software updates, accessory additions, UI changes, and incremental performance/design refinements while maintaining core technology and indications ^{2391498660284169131}.

Microwave ablation and accessories

Oncology and soft-tissue ablation systems

• Varian IntelliBlate Microwave Ablation System (2024): 2.45 GHz microwave for soft-tissue ablation, including liver tumors; cleared via 510(k) as substantially equivalent to Emprint and NEUWAVE systems ^239237238.
• Medtronic Emprint Ablation System with Thermosphere (2024): 2.45 GHz microwave; Special 510(k) updating instructions for use/surgical techniques; intended for liver ablation in percutaneous, laparoscopic, and intraoperative settings ^149150147145.
• NEUWAVE Microwave Ablation System (2022, 2023 updates): 2.45 GHz microwave for soft-tissue ablation including non-resectable liver tumors; multiple 510(k) iterations updating hardware/software while maintaining core tech ^323433868987.
• AngioDynamics Solero Microwave Tissue Ablation System (2023): 2.45 GHz microwave for soft-tissue ablation during open procedures; cleared via multiple 510(k)s with software/applicator refinements ^{133134137138135}.
• Betters (Suzhou) Microwave Ablation System BD-GT (2023): 2.45 GHz for soft-tissue ablation; 510(k) SE to predicate K201262 ⁹⁶⁹⁴⁹².
• Hygea Exceed S10U Microwave Ablation Device with Sterile Probe (2024): 2.45 GHz for coagulation and ablation of soft tissue; 510(k) with NEY product code ^210206208.
• Canyon Medical KY-2000A/KY-2100A Microwave Ablation Generators (2024): 2.45 GHz for soft-tissue ablation; 510(k) K241827 ⁶¹².
• Mima-Pro SurBlate Ablation System (2023): 2.45 GHz thermoablation of soft tissue; 510(k) SE to HS AMICA ²⁷²⁵³⁰.

Microwave instruments/accessories

• Betters Disposable Microwave Ablation Needles (2023): disposable antennas for microwave coagulation/necrosis; 510(k) SE to K201265 ^114113112.
• Canyon Microwave Ablation Antennas (2024): accessory antennas for microwave soft-tissue ablation; 510(k) SE to K201265 ^166165167.

Microwave in dermatology/podiatry and GI

• Emblation swiftPro/Swift Systems (2025): surface microwave therapy for common and plantar warts; 510(k) K250718; Class II NEY ^1029899.
• Creo Medical Electrosurgical System with NP1/AB1 Instruments (2023): 5.8 GHz microwave for soft-tissue coagulation/ablation; 510(k) updates to accessories/instructions ^281277187191.

Radiofrequency (RF) devices

Bone/spine oncology and pain

• Medtronic OsteoCool 2.0 RF Ablation System (2024): bipolar cooled RF for ablation in bone (e.g., vertebral metastases, osteoid osteoma); 510(k) iteration ^222218300.
• Stryker OptaBlate RF Generator, Probes, Microinfuser (2022; 2025 update): bipolar RF for bone/spine tumor ablation and pain palliation; 2025 update adds flexible probe kits; 510(k) SE to K221074 ^{605558284285287}.
• Axon Spine Spinery RF Ablation System (2023): RF thermal ablation of spine metastatic tumors via percutaneous access; 510(k) SE to OsteoCool/OptaBlate ^194195193.

Cardiac surgical ablation

• AtriCure Isolator Synergy EnCapture Clamp (EMH) (2024): bipolar RF clamp for ablating cardiac tissue; 510(k) SE to prior Isolator Synergy ^274272271.
• AtriCure Isolator Linear/Transpolar Pens, Coolrail, Synergy Systems and Clamps (2022): bipolar RF for cardiac tissue ablation; 510(k) clearances across multiple handpieces/generators ^616263646566.
• Medtronic Cardioblate Gemini-s Surgical Ablation Devices (2022): bipolar RF (∼434 kHz) with saline irrigation to create Cox‑Maze lesion patterns during cardiac surgery; 510(k) ^176177178.

Vascular/endovenous

• Medtronic ClosureFast Endovenous RF Ablation Catheter (2023): endovascular RF for superficial vein reflux ablation; 510(k) update ¹⁶¹³.
• Zhejiang CuraWay Endovenous RF Generator and Catheter (2024): RF for vessel/tissue coagulation in superficial vein reflux; 510(k) SE to VNUS predicates ^225224223.

GI/abdominal and general soft tissue

• Innoblative SIRA RFA Electrosurgical Device (2023): intraoperative coagulation and ablation of soft tissue during open abdominal surgery; bipolar RF with saline; 510(k) ⁸⁴⁸¹⁸⁰.
• Compal AblatePal RF Ablation System (2023): monopolar RF for coagulation/ablation in percutaneous/laparoscopic/intraoperative procedures; 510(k) SE to Cool-tip ^201199291.
• Mygen M-3004 RF Generator (2022): high-frequency RF generator (up to 200 W) for coagulation/ablation, including partial/complete liver tumor ablation; 510(k) K221277 ^257253258.
• Zhejiang CuraWay RF Generator and Electrode (2024): ∼480 kHz RF for tissue coagulation/ablation in percutaneous, laparoscopic, and intraoperative procedures; 510(k) ^153154155.
• Medtronic OneRF Trigeminal Nerve RF Probes (NeuroOne) (2025): RF lesioning of trigeminal nerve for pain and functional neurosurgery; 510(k) under 21 CFR 882.4725, GXI ⁴²³⁷⁴⁰.

Arthroscopy/orthopedics and ENT

• ArthroCare Ambient HipVac 50 Wand with COBLATION Systems (2022): bipolar RF for resection/ablation and hemostasis in arthroscopic/orthopedic procedures; 510(k) ^115119120.
• DELPHI System (2025): bipolar high-RF generator and electrodes for tissue coagulation/ablation and hemostasis in arthroscopic surgery; 510(k) ⁷¹².
• ArthroCare ARIS COBLATION Turbinate Reduction Wand; WEREWOLF/WEREWOLF+ COBLATION (2023): bipolar RF for turbinate reduction and soft-tissue ablation/coagulation in ENT and orthopedic contexts; 510(k) ^242244245.

Gynecology

• Gynesonics Sonata Transcervical Fibroid Ablation System 2.2 (2022; 2023 sterilization update): transcervical RF ablation of uterine fibroids under integrated ultrasound guidance; 510(k) iterations ^{2302322945149}.

Dermatology/aesthetic RF

• EndyMed PRO MAX (2025): non-invasive bipolar RF for mild–moderate facial wrinkles, pain relief indications (muscle aches/spasm, circulation); 510(k) K242996 ^260263264.
• Legend X Desktop System and Applicator VO (2024): RF-based skin ablation/resurfacing (VoluDerm), electrocoagulation/hemostasis, muscle conditioning; 510(k) K243217; VO adds genXL tip ^{211214216183181}.
• Eunsung DUET‑V (2025): 4 MHz fractional and thermal RF tips for dermatologic ablation/resurfacing and electrocoagulation; 510(k) K233118 ^266267270.

Hybrid and multi-modality platforms

RF + Microwave (endoscopy/GI surgery)

• Creo SpydrBlade Flex (2025): RF cutting (400 kHz) plus 5.8 GHz microwave coagulation via a dual‑modality endoscopic instrument for GI procedures; 510(k) K242774 ^143139140.
• Creo CROMA Electrosurgical Generator (2025): delivers bipolar RF and microwave (5.8 GHz) energy for cutting, coagulation, and ablation; 510(k) SE to K230328/K223138 ⁶⁹⁶⁸⁷⁰.
• Creo Reusable Interface Cable (2024): accessory enabling RF/MW delivery from CROMA to GI instruments; 510(k) under 21 CFR 876.4300, KNS ¹⁰⁴¹⁰⁵.

RF + Laser (dermatology)

• Rohrer PiXel8‑Reveal (2024): combines 4 MHz bipolar RF microneedling with a 2940 nm Er:YAG laser for superficial skin ablation, wrinkles, and soft-tissue cutting/coagulation; 510(k) ^20221924.

RF + helium plasma (electrosurgical/aesthetic)

• Apyx Renuvion APR Handpiece (2023, 2022): monopolar RF delivered via helium plasma for cutting, coagulation, ablation, and subcutaneous aesthetic tissue contraction (e.g., neck/submental laxity; post‑liposuction coagulation); 510(k) iterations ^{787376169170174}.
• Apyx One Console (2022): delivers RF and/or helium plasma for open/laparoscopic tissue cutting/coagulation/ablation; 510(k) ^252247248.

Nonthermal electrosurgical ablation

• Pulse Biosciences CellFX Percutaneous Electrode System (2024): nanosecond Pulsed Field Ablation (nsPFA) for nonthermal soft-tissue ablation via high‑amplitude nanosecond bipolar pulses; 510(k) Class II under 21 CFR 878.4400, GEI ^131130129132.

Software adjunct to energy-based therapies

• TechsoMed BioTraceIO Precision (2.0) (2024): software to assist clinical assessment of ablation zones after RF or microwave liver ablation by correlating maps with contrast‑enhanced CT; 510(k) K243084 (product code QZL); does not deliver energy ^158157160.

Additional modality notes and use-cases

• Endovenous vein ablation: Besides ClosureFast, Zhejiang CuraWay’s endovenous RF generator/catheter adds competition in superficial vein reflux treatment with 510(k) equivalence to VNUS systems ^225226223.
• GI electrosurgery hybrids: Erbe HybridTherm introduced a high-frequency electrosurgical platform with CO2 cooling and multiple probes for cutting, coagulation, and ablation; cleared via Traditional 510(k) with SE to ESU VIO 3 and EUSRA RF electrodes ^122123125121.
• Broader GI ablation ecosystem: Creo NP1/AB1 instruments and updates, CROMA generator, and interface accessories reinforce a trend toward dual‑modality (RF+MW) endoscopic platforms with 510(k) updates focusing on software and usability rather than fundamental technology changes ^{28127718718869104}.

Regulatory and novelty pattern (what changed, what didn’t)

• Pathway: Nearly all devices above were cleared through the FDA 510(k) premarket notification pathway as Class II devices (e.g., microwave ablation NEY; electrosurgical GEI; GI endoscopy KNS), reflecting substantial equivalence to predicates and avoiding PMA/De Novo burdens ^{2396133168469143252}.
• Iterative innovation: Submissions frequently cite changes such as software updates, UI/display changes, accessory additions, sterilization options, probe variants, and IFU refinements, while retaining core modality, indications, and principles of operation (e.g., Emprint Special 510(k); NEUWAVE hardware/software updates; OptaBlate new probe kits) ^14986284.
• Novel energy: Even with nsPFA entering percutaneous soft‑tissue ablation, FDA classified it within electrosurgical cutting/coagulation devices and cleared it via 510(k) by demonstrating no new safety/effectiveness questions versus predicates ¹³¹.

What this means

• Choice breadth: Clinicians now have an expanded selection of microwave and RF systems across specialties, with more tailored probes, frequencies (e.g., 2.45 vs 5.8 GHz), and hybrid modalities improving hemostasis, precision, and workflow—particularly in liver oncology, spine oncology/pain, GI endoscopy, and cardiac surgery ^{23914960143176}.
• Aesthetic and office-based expansion: Multiple RF and plasma-based platforms, plus hybrid RF+laser, target skin resurfacing, subcutaneous tissue contraction, and wrinkle treatment with incremental usability upgrades, broadening adoption in dermatology and plastics ^2078211260.
• Interoperable ecosystems: Endoscopic platforms (e.g., CROMA with RF+MW instruments/cables) highlight a trend toward modular ecosystems enabling combined cutting/coagulation within a single generator and workflow ^69143104.
• Regulatory predictability: The preponderance of 510(k) clearances and substantial equivalence determinations underscores a mature, iterative innovation cycle for energy-based devices, facilitating steady market entry while maintaining established safety/effectiveness profiles ^23913316252.

If you want, I can tailor this landscape by specialty or indication (e.g., liver ablation, cardiac surgery, endovenous vein care, dermatology) and map device options to procedural settings and accessory ecosystems, along with year-by-year activity and sponsor pipelines using the entries above.