Technology

HIFU & Ultrasound Devices (2026)

27 devices tracked · RF Microneedling, Tightening & HIFU · Facial & Wellness · Body Contouring

Get a free recommendation Compare devices

All 27 hifu & ultrasound systems, with pricing and FDA status

		Subcategory	Technology				Status
Aesthetics Biomedical	Vivace Ultra	RF Microneedling	RF microneedling + ultrasound skin visualization	2023	$60k–$90k	—	CurrentFDA Cleared
Alma	TED+	Hair restoration	Ultrasound-based topical delivery for hair restoration	—	$180k–$225k	$45.5k	CurrentFDA Cleared
Alma Lasers	Accent Prime	RF body contouring	Ultrasound + unipolar RF	2016	$80k–$120k	$25k–$55k	CurrentFDA Cleared
Alma Lasers	Accent Ultra	RF body contouring	RF + cold ultrasound	2012	—	$8k–$18k	DiscontinuedFDA Cleared
Alma Lasers	Alma PrimeX	RF body contouring	High-power RF + ultrasound	2022	$100k–$160k	—	CurrentFDA Cleared
Alma Lasers	JuVaShape	RF body contouring	RF + ultrasound body shaping	2015	—	$5k–$15k	DiscontinuedFDA Cleared
BTL Aesthetics	Exilis Elite	RF body contouring	Higher-power RF + ultrasound	2013	—	$11.5k–$22k	Legacy-used-marketFDA Cleared
BTL Aesthetics	Exilis Ultra 360	RF body contouring	RF + ultrasound, 360 applicators	2016	$60k–$90k	$20k–$45k	CurrentFDA Cleared
BTL Aesthetics	Exion	RF body contouring	Monopolar RF + targeted ultrasound (body applicator)	2023	$150k–$200k	—	CurrentFDA Cleared
Classys	Shurink Universe	HIFU/Ultrasound Lifting	Dual-mode HIFU	2022	—	$10k–$20k	CurrentNo US 510(k) located
Classys	Ultraformer III	HIFU/Ultrasound Lifting	7-cartridge HIFU face/body	2016	—	$20.7k–$47.9k	CurrentNo US 510(k) located
Classys	Ultraformer MPT	HIFU/Ultrasound Lifting	Micro-pulsed HIFU (2mm boost mode)	2023	$40k–$70k	$25k–$45k	CurrentNo US 510(k) located
Hironic	Doublo Gold	HIFU/Ultrasound Lifting	HIFU lifting	2016	—	$5k–$12k	Legacy-used-marketNo US 510(k) located
Jeisys	ULTRAcel	HIFU/Ultrasound Lifting	HIFU + fractional RF + RF microneedling combo	2015	—	$8k–$18k	Legacy-used-marketNo US 510(k) located
Jeisys	ULTRAcel Q+	HIFU/Ultrasound Lifting	Linear+dot HIFU cartridge system	2018	—	$10k–$20k	CurrentNo US 510(k) located
Jeisys	ULTRAcel Zii	HIFU/Ultrasound Lifting	Linear-firing HIFU + RF	2022	—	$15k–$30k	CurrentNo US 510(k) located
Korust	UTIMS A3	HIFU/Ultrasound Lifting	HIFU lifting	2015	—	$3k–$8k	Legacy-used-marketNo US 510(k) located
Merz	Cellfina	Cellulite treatment	Vacuum-assisted subcision device	2015	$50k–$90k	$10k–$25k	DiscontinuedFDA Cleared
Merz Aesthetics	Ultherapy PRIME	HIFU/Ultrasound Lifting	Next-gen MFU-V with enhanced imaging	2024	$150k–$200k	—	CurrentFDA Cleared
Sofwave	Pure Impact	EMS/HIFEM muscle stimulation	Electromagnetic muscle stimulation	—	—	—	CurrentFDA Cleared
Sofwave Medical	Sofwave	HIFU/Ultrasound Lifting	Synchronous Ultrasound Parallel Beam (SUPERB)	2021	$100k–$150k	$60k–$95k	CurrentFDA Cleared
Solta	VASERshape MC1	Ultrasound/HIFU fat reduction	External ultrasound + massage	2010	—	$8k–$20k	DiscontinuedFDA Cleared
Solta Medical	Liposonix	Ultrasound/HIFU fat reduction	High-intensity focused ultrasound	2011	—	$10k–$30k	DiscontinuedFDA Cleared
Solta Medical	VASERlipo	Ultrasound-assisted lipolysis (internal)	Ultrasound-assisted liposuction	2007	$100k–$150k	$25k–$60k	CurrentFDA Cleared
Syneron-Candela	UltraShape	Ultrasound/HIFU fat reduction	Pulsed focused ultrasound (non-thermal)	2014	—	$10k–$25k	Legacy-used-marketFDA Cleared

Swipe the table for more columns →

Showing 25 of 27 matching devices (27 in this set).

HIFU & Ultrasound head-to-head comparisons

Sofwave vs Ultherapy Ultherapy vs Ultraformer MPT Shurink Universe vs Ultraformer III Cellfina vs Exilis Ultra 360 Exilis Ultra 360 vs Sofwave

Parent categories for HIFU & Ultrasound

RF Microneedling, Tightening & HIFU Facial & Wellness Body Contouring

Frequently asked questions

How many hifu & ultrasound devices are tracked?: We track 27 hifu & ultrasound platforms sold in the US, each with FDA status, published price ranges where we have them, and recorded chain adoption.
How much does a hifu & ultrasound machine cost?: Across the 13 hifu & ultrasound devices with a published new range, our researched US market pricing runs $40k–$225k. These are researched market ranges, not manufacturer quotes; each device profile carries its own source note.
Are hifu & ultrasound devices FDA cleared?: 19 of the 27 hifu & ultrasound devices we track carry a 510(k) clearance we have evidenced. FDA status is per device and per indication, so check the individual profile before relying on it.
Can you buy hifu & ultrasound devices used?: We publish a used asking range for 22 of the 27 hifu & ultrasound devices we track. Used asking ranges are observed market asks, not transaction prices.