510(k) Report

FDA applicant

Aaren Scientific

Ontario3 decisions1998–20133 recalls

FDA records 3 decisions for Aaren Scientific (Ontario) from 1998 to 2013: 1 510(k) clearance and 2 original PMA approvals. Most are in product codes HQL (Intraocular Lens) and MSS (Folders And Injectors, Intraocular Lens (Iol)). Its devices cite 1 predicate, 0 of them its own earlier devices. 3 recalls are linked to its devices.

FDA’s records also spell it “Aaren Scientific, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Aaren Scientific’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2017

2011: 22017: 1
2007high 2 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Aaren Scientific by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HQLIntraocular Lens2decisions
  • MSSFolders And Injectors, Intraocular Lens (Iol)1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K123888Z Cartridge Iol Delivery SystemAaren Scientific, Inc. · 20131 recall
  • P010027Anterior Chamber Intraocular Lens (Cataract)Aaren Scientific · 2001
  • P970034Modified C-Loop, UV-Absorbing Posterior Chamber Intraocular LensesAaren Scientific · 19982 recalls

All 2 as Aaren Scientific →The one decision as Aaren Scientific, Inc. →

What has been recalled?

3 recalls linked to its devices; the latest:

  • K123888AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282…Sep 1, 2017Class II
  • P970034UV-Absorbing Posterior Chamber IOL Model: RS-55B, Serial Number: 1167121106, 1167131106…Aug 2, 2011
  • P970034UV-Absorbing Posterior Chamber IOL Model: SP-65A2, Serial Number: 1168471106…Aug 2, 2011