510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K971609Substantially Equivalent

Sculpture

Servizi Medico Estetici Italinai SRL., Casale Monferrato (Al), IT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K971609 is the FDA 510(k) clearance record for SCULPTURE, cleared for Servizi Medico Estetici Italinai Srl. on under FDA product code LFL (Instrument, Ultrasonic Surgical). FDA records list 2 510(k) clearances for Servizi Medico Estetici Italinai Srl., from to . As of , FDA records show no recalls naming K971609.

Clearance record

Decision date
Received
(105 days to decision)
Product code
LFL Instrument, Ultrasonic Surgical
Device class
Unclassified
Review panel
Unknown
Applicant
Servizi Medico Estetici Italinai Srl. 15 Via F. Negri, Casale Monferrato (Al), IT
510(k) summary
Statement
Third party review
No

Clearances, product code LFL

Trailing 12 months
1 clearance under product code LFL in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LFL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260