FDA product code HLP: Target, Fusion And Stereoscopic
HLP is the FDA product code for target, fusion and stereoscopic. It is a Class I device, regulated under 21 CFR 886.1880 and reviewed by the Ophthalmic panel. FDA has cleared 3 510(k) submissions under HLP, from 2 different applicants. The average 510(k) review took 84 days (median 84).
Classification
| Field | Value |
|---|---|
| Device name | Target, Fusion And Stereoscopic |
| Device class | Class I |
| Regulation | 21 CFR 886.1880 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HLP clearance
Top HLP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Richmond Products, Inc. | 2 | 1988-01-11 |
| Technitex, Inc. | 1 | 1988-11-08 |
Most recent HLP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K883471 | Technitex, Inc. | VKG 1000, VIDEO KERATOMETER | 1988-11-08 | 84 |
| K874251 | Richmond Products, Inc. | WORTH 4 DOT TEST DISTANCE C/W MUSCLE LIGHT | 1988-01-11 | 84 |
| K874250 | Richmond Products, Inc. | THREE CHAR. TEST-CHILD & WORTH 4 DOT TEST NEARPT. | 1988-01-11 | 84 |
Recalls for HLP devices
openFDA lists no recalls for product code HLP.
Frequently asked questions
What is FDA product code HLP?
HLP is the FDA product code for target, fusion and stereoscopic. It is a Class I device, regulated under 21 CFR 886.1880 and reviewed by the Ophthalmic panel.
What device class is HLP?
Class I, regulation 21 CFR 886.1880. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HLP?
Across 3 cleared submissions the average was 84 days from receipt to decision (median 84).
Which companies have the most HLP clearances?
Richmond Products, Inc. (2); Technitex, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HLP
- Run a recall and safety report across every HLP manufacturer
- Watch product code HLP 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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