510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K992687Substantially Equivalent

Millenium Microkeratome, Model Imd-001

Industrial & Medical Design, Inc., Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992687 is the FDA 510(k) clearance record for MILLENIUM MICROKERATOME, MODEL IMD-001, a class I device, cleared for Industrial & Medical Design, Inc. on under FDA product code HMY (Keratome, Battery-Powered). FDA records list 3 510(k) clearances for Industrial & Medical Design, Inc., from to . As of , FDA records show no recalls naming K992687.

Clearance record

Decision date
Received
(45 days to decision)
Product code
HMY Keratome, Battery-Powered
Regulation
21 CFR 886.4370
Device class
Class I
Review panel
Ophthalmic
Applicant
Industrial & Medical Design, Inc. 6230 Wilshire Blvd., Suite 410, Los Angeles CA
510(k) summary
Summary
Third party review
No

Clearances, product code HMY

Trailing 12 months

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

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