FDA product code PIC: Oral Electronic Vision Aid

PIC is the FDA product code for oral electronic vision aid. It is a Class II device, regulated under 21 CFR 886.5905 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under PIC. The average 510(k) review took 86 days (median 86). 1 De Novo request was granted under it. FDA has posted 1 recall for PIC devices.

Definition

To use as an oral electronic vision aid in conjunction with other assistive devices (e.g., the white cane, guide dog, etc.)

Classification

Compare with all 510(k) review times · Search every PIC clearance

Top PIC applicants

Most recent PIC clearances

Recalls for PIC devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-01-14.

Frequently asked questions

What is FDA product code PIC?

PIC is the FDA product code for oral electronic vision aid. It is a Class II device, regulated under 21 CFR 886.5905 and reviewed by the Ophthalmic panel.

What device class is PIC?

Class II, regulation 21 CFR 886.5905. Typical premarket route: 510(k).

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

Across 1 cleared submissions the average was 86 days from receipt to decision (median 86).

Which companies have the most PIC clearances?

Wicab, Inc. (1).

Have PIC devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2019-01-14.

Next steps

• Run an FDA pathway report with predicate devices for product code PIC
• Run a recall and safety report across every PIC manufacturer
• Watch product code PIC 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.

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