510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011273Substantially Equivalent

Si Ascope

Astron Clinica Limited, Crofton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011273 is the FDA 510(k) clearance record for SI ASCOPE, a class II device, cleared for Astron Clinica Limited on under FDA product code PSN (Light Based Imaging). FDA's definition for product code PSN reads: "Emission and collection of light to create an image for medical purposes". FDA records list 3 510(k) clearances for Astron Clinica Limited, from to . As of , FDA records show no recalls naming K011273.

Clearance record

Decision date
Received
(300 days to decision)
Product code
PSN Light Based Imaging
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Astron Clinica Limited P.O. Box 4341, Crofton MD
510(k) summary
Statement
Third party review
No

Clearances, product code PSN

Trailing 12 months

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

FDA records show no clearances under product code PSN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PSN, 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