How does HIFU (ultrasound) lifting work?
HIFU (ultrasound) lifting is a non-invasive treatment that focuses ultrasound energy at set depths beneath the skin to create tiny thermal coagulation points.
Understanding Lifting · Q8
Ultherapy PRIME: HIFU Lifting Guided by Ultrasound Imaging
Question: What is Ultherapy PRIME and how does it work?
Short answer
Ultherapy PRIME is a lifting device that focuses high-intensity focused ultrasound (HIFU) energy at set depths beneath the skin to create thermal coagulation points, and it allows the area beneath the skin to be viewed on ultrasound imaging during treatment. The manufacturer explains that the final result appears over 2 to 3 months, and results differ from person to person. Side effects such as redness, swelling, tenderness, bruising and temporary nerve symptoms have been reported.
Key points
- A HIFU lifting device that creates thermal coagulation points with focused ultrasound
- DeepSEE imaging shows up to 8 mm beneath the skin
- Uses transducers with focal depths of 1.5 mm, 3.0 mm and 4.5 mm
- Manufacturer: final results appear over 2 to 3 months
- Clinical reports: swelling 3 to 72 hours, tenderness and bruising 2 days to 2 weeks (varies)
What kind of device is Ultherapy PRIME?
Ultherapy PRIME is a high-intensity focused ultrasound (HIFU) lifting device made by Ulthera, Inc.
It focuses ultrasound energy at a specific depth beneath the skin to create tiny thermal coagulation points, and this heat is described as stimulating collagen contraction and new collagen production in the SMAS and deep dermis. The official website is run by Merz Aesthetics (as of 2026).
In Korea, it is approved by the MFDS as medical device import approval number 09-1024, a Class 3 device under the product name 'focused ultrasound stimulation system', and the importer is Merz Asia Pacific (as of 2026, subject to change).
| Date | Clearance | Details |
|---|---|---|
| 2009-09-11 | FDA De Novo clearance (DEN080006) | Non-invasive eyebrow lift |
| 2012-10-02 | FDA 510(k) clearance (K121700) | Added lifting of lax tissue on the submental area and neck |
| 2014-06-20 | FDA 510(k) clearance (K134032) | Added improvement of lines and wrinkles on the decolletage (upper chest) |
| 2024-02-22 | FDA 510(k) clearance (K233996) | PRIME console design, screen and hardware update |
| 2025-02-24 | FDA 510(k) clearance (K243035) | Added improvement in the appearance of skin laxity on the abdomen, front of the arms and back of the arms |
What role does real-time ultrasound imaging play?
The DeepSEE transducer shows ultrasound images up to 8 mm beneath the skin and is used to check that the transducer is in proper contact and at an appropriate depth, for example avoiding bone.
The treatment focal depth depends on the transducer: 1.5 mm (10 MHz), 3.0 mm (7 MHz) and 4.5 mm (4 MHz or 7 MHz), and the imaging range is 0 to 8 mm.
The manufacturer explains that the skin is assessed with real-time ultrasound imaging so treatment can be individualized.
How is the PRIME model different from the previous device?
Ultherapy PRIME is a model with a modernized console exterior and screen (GUI) and hardware updated to current electromedical standards.
The summary of the FDA 510(k) clearance of February 22, 2024 (K233996) states that the ultrasound signal energy and treatment guidelines are the same as the previous device. In other words, the treatment principle is the same, and what changed is the environment in which the device is used.
When do results appear and how long do they last?
The manufacturer explains that some initial lifting may be felt, but the final result appears over 2 to 3 months as new collagen forms.
The manufacturer explains that effects on the face may last a year or longer, and on the abdomen and arms up to 6 months, and states that results differ from person to person. Treatment takes about 30 to 90 minutes depending on the area.
It is described as suitable for mild to moderate sagging, and it is also noted that surgery should be considered when sagging is severe.
What side effects can occur?
Side effects reported in clinical studies include redness, swelling, welts (linear swelling), discomfort, tenderness and bruising, and most were mild and temporary.
In face and neck studies, redness usually resolved within a few hours, swelling within 3 to 72 hours, welts within 1 week, post-treatment discomfort within 2 hours to 2 days, and tenderness and bruising within 2 days to 2 weeks. Nerve effects such as temporary muscle weakness, numbness and tingling usually resolved within 2 to 6 weeks.
Improper technique can cause burns and scarring, and nerve effects lasting several months have also been reported after the device came to market. If symptoms last longer than expected or anything unusual appears, it is a good idea to contact the clinic.
FAQ
Are there cases where Ultherapy PRIME should not be used?
It is contraindicated if there are open wounds or severe acne in the treatment area, or if you have an active implanted device such as a pacemaker or defibrillator, or metal implants in the treatment area. Treatment directly over fillers or implants, and during pregnancy or breastfeeding, has not been evaluated, so let the clinic know during the consultation.
How is the number of shots decided?
CELITA Clinic decides the number of shots by considering skin firmness, the size of the area and the result you hope for, together with objective data such as AI measurements. Skin condition is checked with EVE V MUSE and Sono Finder before treatment.
Can I have it if I have a medical device such as a cochlear implant?
The instructions for use warn that the device should be kept at least 15 cm away from magnetically sensitive medical devices such as cochlear implants, nerve stimulators, stents and shunts. If you have such a device, be sure to mention it during the consultation.
Important
This article is general medical information, not a diagnosis or treatment. Results, recovery time and side effects vary with each person's skin, and whether a treatment suits you is decided after consultation with a doctor. If you notice unusual symptoms, contact the clinic that treated you right away.
Sources
All questions in Understanding Lifting
- Q8. How does HIFU (ultrasound) lifting work?
- Q9. What is Ultherapy PRIME and how does it work?
- Q10. What is Thermage FLX and how does it work?
- Q11. What is Onda lifting and how does it work?
- Q12. What is Shurink Universe and how does it work?
- Q13. How is the number of shots for a lifting treatment decided?
- Q14. Does a lifting treatment hurt a lot, and how is numbing done?
- Q15. When do lifting results appear and how long do they last?
- Q16. How is a thread lift different from device-based lifting?