510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040525Unknown

Sonoprep Ultrasonic Skin Permeation System and Topical Anesthetic Kit, Model D2000

Sontra Medical, Inc., Franklin MA / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040525 is the FDA 510(k) clearance record for SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000, a class II device, cleared for Sontra Medical, Inc. on under FDA product code NRJ (Ultrasound, Skin Permeation). FDA's definition for product code NRJ reads: "Indicated for the temporary disruption of the outer layer of skin for the application of drugs, etc". FDA records list 2 510(k) clearances for Sontra Medical, Inc., from to . As of , FDA records show no recalls naming K040525.

Clearance record

Decision date
Received
(169 days to decision)
Product code
NRJ Ultrasound, Skin Permeation
Regulation
21 CFR 878.4410
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Sontra Medical, Inc. 10 Forge Pkwy., Franklin MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NRJ

Trailing 12 months

FDA records hold no clearances under product code NRJ in the trailing twelve months.

FDA records show no clearances under product code NRJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NRJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260