510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853876Substantially Equivalent

Endo-Lse Cd-100 CO2 Laser for Gynecology

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

K853876 is the FDA 510(k) clearance record for ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY, a class II device, cleared for Endo Lase, Inc. on under FDA product code HHR (Laser, Surgical, Gynecologic). FDA records list 24 510(k) clearances for Endo Lase, Inc., from to . As of , FDA records show no recalls naming K853876.

Clearance record

Decision date
Received
(157 days to decision)
Product code
HHR Laser, Surgical, Gynecologic
Regulation
21 CFR 884.4550
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Endo Lase, Inc. Attn: Jonathan S. Kahan, Washington DC
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