510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970320Substantially Equivalent

Scleral Shell

Xavier A. Guerra, Ocularist, Inc., San Antonio TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970320 is the FDA 510(k) clearance record for SCLERAL SHELL, a class II device, cleared for Xavier A. Guerra, Ocularist, Inc. on under FDA product code HQT (Shell, Scleral). FDA records list 2 510(k) clearances for Xavier A. Guerra, Ocularist, Inc. As of , FDA records show no recalls naming K970320.

Clearance record

Decision date
Received
(160 days to decision)
Product code
HQT Shell, Scleral
Regulation
21 CFR 886.3800
Device class
Class II
Review panel
Ophthalmic
Applicant
Xavier A. Guerra, Ocularist, Inc. 4640 Centerview Dr., San Antonio TX
510(k) summary
Statement
Third party review
No

Clearances, product code HQT

Trailing 12 months

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

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