510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861845Substantially Equivalent

Model 8-B with La-2B Attachment for Ob-Gyn Use

Directed Energy, Inc., Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861845 is the FDA 510(k) clearance record for MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE, a class II device, cleared for Directed Energy, Inc. on under FDA product code HHR (Laser, Surgical, Gynecologic). FDA records list 39 510(k) clearances for Directed Energy, Inc., from to . As of , FDA records show no recalls naming K861845.

Clearance record

Decision date
Received
(90 days to decision)
Product code
HHR Laser, Surgical, Gynecologic
Regulation
21 CFR 884.4550
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Directed Energy, Inc. 11661 San Vicente Blvd., Los Angeles CA
Third party review
No

Clearances, product code HHR

Trailing 12 months

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

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