FDA product code HQG: Lens, Spectacle, Non-Custom (Prescription)
HQG is the FDA product code for lens, spectacle, non-custom (prescription). It is a Class I device, regulated under 21 CFR 886.5844 and reviewed by the Ophthalmic panel. FDA has cleared 56 510(k) submissions under HQG, from 48 different applicants. The average 510(k) review took 55 days (median 42). FDA has posted 4 recalls for HQG devices.
Classification
| Field | Value |
|---|---|
| Device name | Lens, Spectacle, Non-Custom (Prescription) |
| Device class | Class I |
| Regulation | 21 CFR 886.5844 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every HQG clearance
Top HQG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Optical Corp. | 4 | 1981-09-08 |
| Seiko Optical Products of America, Inc. | 2 | 1987-10-05 |
| Aura Lens Products | 2 | 1987-07-27 |
| Barnes-Hind, Inc. | 2 | 1981-07-02 |
| Gentex Corporation | 2 | 1980-03-12 |
43 more applicants have HQG clearances. See the full list in Caduvo.
Most recent HQG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K935919 | Ja-Ru, Inc. | SUNGLASSES | 1994-02-16 | 70 |
| K920795 | Optical Radiation Corp. | 0R 160, OR-1.60, AND ORCOLITE 1.60 HIGH INDEX | 1992-07-13 | 143 |
| K900091 | Onufryk Low Vision Ent. | MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR | 1990-04-04 | 89 |
| K884360 | Seiko Corp. | SEIKO P-6 PROGRESSIVE SPECTACLE LENSES | 1988-11-15 | 29 |
| K882814 | Neolens, Inc. | NEOLENS PRESCRIPTION SPECTACLE LENS | 1988-07-29 | 21 |
Recalls for HQG devices
4 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-03-18.
| Year | Recalls |
|---|---|
| 2020 | 1 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- J8499 — Prescription drug, oral, non chemotherapeutic, nos
Frequently asked questions
What is FDA product code HQG?
HQG is the FDA product code for lens, spectacle, non-custom (prescription). It is a Class I device, regulated under 21 CFR 886.5844 and reviewed by the Ophthalmic panel.
What device class is HQG?
Class I, regulation 21 CFR 886.5844. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HQG?
Across 56 cleared submissions the average was 55 days from receipt to decision (median 42).
Which companies have the most HQG clearances?
American Optical Corp. (4); Seiko Optical Products of America, Inc. (2); Aura Lens Products (2); Barnes-Hind, Inc. (2); Gentex Corporation (2).
Have HQG devices been recalled?
Yes: 4 product recalls across 4 recall events; the most recent began 2020-03-18.
Next steps
- Run an FDA pathway report with predicate devices for product code HQG
- Run a recall and safety report across every HQG manufacturer
- Watch product code HQG 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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