21 CFR 878.4590
Focused ultrasound stimulator system for aesthetic use
21 CFR 878.4590 is the regulation titled “Focused ultrasound stimulator system for aesthetic use” in 21 CFR Part 878, General and Plastic Surgery Devices. Since 2021, 1 FDA warning letter has cited it.
- Letters citing it
- 1 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 807.81, in 1 letter
- Closed out
- 100% of these letters have a published close-out
Letters citing it, by year issued
It is a medical device letter. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 12022
- 02023
- 02024
- 02025
- 02026
What FDA writes when it cites it
The finding headings that cite 21 CFR 878.4590 most often, as written in the letters.
- 1 letterFDA has reviewed your firm’s website (www.skinsheek.com) and determined that the LIFT is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved…
The regulation
Read the text of 21 CFR 878.4590 (eCFR, as of Sep 1, 2026)
(a) Identification. A Focused Ultrasound Stimulator System for Aesthetic Use is a device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for noninvasive aesthetic use.
(b) Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.
[76 FR 43121, July 20, 2011]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 878.4590.
- 21 CFR 807.81When a premarket notification submission is required1 letter cites both
- 21 CFR 878.4400Electrosurgical cutting and coagulation device and accessories1 letter cites both
- 21 CFR 878.4810Laser surgical instrument for use in general and plastic surgery and in dermatology1 letter cites both
- 21 CFR 878.5350Needle-type epilator1 letter cites both
- 21 CFR 878.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)1 letter cites both
- 21 CFR 890.9Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act)1 letter cites both
Latest letters citing it
The letter citing 21 CFR 878.4590 that FDA posted most recently.
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Counts include every citation in a letter, as the Letters filter does. How this database is built.