510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081698Substantially Equivalent

Mainstream or Surgical Light Control (Mslc)

Image Stream Medical, Inc., Winchester MA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081698 is the FDA 510(k) clearance record for MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC), a class II device, cleared for Image Stream Medical, Inc. on under FDA product code FTA (Light, Surgical, Accessories). FDA records list 2 510(k) clearances for Image Stream Medical, Inc., from to . As of , FDA records show no recalls naming K081698.

Clearance record

Decision date
Received
(43 days to decision)
Product code
FTA Light, Surgical, Accessories
Regulation
21 CFR 878.4580
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Image Stream Medical, Inc. 11 Mystic Ave., Winchester MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FTA

Trailing 12 months

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

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