510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K860891Substantially Equivalent

Aivus (7000), Aspiration and Irrigation Device

Intra-Optics Labs. C/O Newman Assoc., Laguna Hills CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860891 is the FDA 510(k) clearance record for AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE, a class II device, cleared for Intra-Optics Labs. C/O Newman Assoc. on under FDA product code HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered). FDA records list one 510(k) clearance for Intra-Optics Labs. C/O Newman Assoc. As of , FDA records show no recalls naming K860891.

Clearance record

Decision date
Received
(42 days to decision)
Product code
HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Regulation
21 CFR 886.4150
Device class
Class II
Review panel
Ophthalmic
Applicant
Intra-Optics Labs. C/O Newman Assoc. 25283 Cabot Rd., Suite 207, Laguna Hills CA
Third party review
No

Clearances, product code HQE

Trailing 12 months

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

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