510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K871706Substantially Equivalent

Optha Prep

Treace Medical, Inc., Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K871706 is the FDA 510(k) clearance record for OPTHA PREP, a class II device, cleared for Treace Medical, Inc. on under FDA product code HMT (Drape, Patient, Ophthalmic). FDA records list 80 510(k) clearances for Treace Medical, Inc., from to . As of , FDA records show no recalls naming K871706.

Clearance record

Decision date
Received
(17 days to decision)
Product code
HMT Drape, Patient, Ophthalmic
Regulation
21 CFR 878.4370
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Treace Medical, Inc. Suite 400, Memphis TN
Third party review
No

Clearances, product code HMT

Trailing 12 months

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

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