510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853580Substantially Equivalent

Medilas 2

Endo Lase, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853580 is the FDA 510(k) clearance record for MEDILAS 2, a class III device, cleared for Endo Lase, Inc. on under FDA product code LKW (Laser, Neurosurgical). FDA records list 24 510(k) clearances for Endo Lase, Inc., from to . As of , FDA records show no recalls naming K853580.

Clearance record

Decision date
Received
(171 days to decision)
Product code
LKW Laser, Neurosurgical
Device class
Class III
Review panel
Unknown
Applicant
Endo Lase, Inc. Attn: Jonathan S. Kahan, Washington DC
Third party review
No

Clearances, product code LKW

Trailing 12 months

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

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