FDA product code HJL: Lens, Condensing, Diagnostic

HJL is the FDA product code for lens, condensing, diagnostic. It is a Class I device, regulated under 21 CFR 886.1380 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under HJL. The average 510(k) review took 246 days (median 246). FDA has posted 1 recall for HJL devices.

Classification

Top HJL applicants

Most recent HJL clearances

Recalls for HJL devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-10-25.

Frequently asked questions

What is FDA product code HJL?

HJL is the FDA product code for lens, condensing, diagnostic. It is a Class I device, regulated under 21 CFR 886.1380 and reviewed by the Ophthalmic panel.

What device class is HJL?

Class I, regulation 21 CFR 886.1380. Typical premarket route: 510(k) exempt.

How long does a 510(k) take for product code HJL?

Across 1 cleared submissions the average was 246 days from receipt to decision (median 246).

Which companies have the most HJL clearances?

Laser Industries , Ltd. (1).

Have HJL devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2012-10-25.

Next steps

• Run an FDA pathway report with predicate devices for product code HJL
• Run a recall and safety report across every HJL manufacturer
• Watch product code HJL for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

All Ophthalmic product codes · FDA product code lookup