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
K950806Substantially Equivalent

Solid Dilicone Implants, Sdilicone Sponge Implants

Mira, Inc., Uxbridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950806 is the FDA 510(k) clearance record for SOLID DILICONE IMPLANTS, SDILICONE SPONGE IMPLANTS, a class II device, cleared for Mira, Inc. on under FDA product code HQX (Implant, Orbital, Extra-Ocular). FDA records list one 510(k) clearance for Mira, Inc. As of , FDA records show no recalls naming K950806.

Clearance record

Decision date
Received
(469 days to decision)
Product code
HQX Implant, Orbital, Extra-Ocular
Regulation
21 CFR 886.3340
Device class
Class II
Review panel
Ophthalmic
Applicant
Mira, Inc. 414 Quaker Hwy., Uxbridge MA
510(k) summary
Summary
Third party review
No

Clearances, product code HQX

Trailing 12 months

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

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