FDA product code HLT: Preamplifier, Ac-Powered, Ophthalmic
HLT is the FDA product code for preamplifier, ac-powered, ophthalmic. It is a Class II device, regulated under 21 CFR 886.1640 and reviewed by the Ophthalmic panel. FDA has cleared 4 510(k) submissions under HLT, from 4 different applicants. The average 510(k) review took 253 days (median 68).
Classification
| Field | Value |
|---|---|
| Device name | Preamplifier, Ac-Powered, Ophthalmic |
| Device class | Class II |
| Regulation | 21 CFR 886.1640 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every HLT clearance
Top HLT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Chalgren Enterprises, Inc. | 1 | 1994-12-07 |
| Tomey Corporation USA | 1 | 1992-07-15 |
| Keller Instruments, Inc. | 1 | 1984-05-09 |
| Sonometrics Systems, Inc. | 1 | 1978-10-24 |
Most recent HLT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K924277 | Chalgren Enterprises, Inc. | DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING | 1994-12-07 | 834 |
| K921815 | Tomey Corporation USA | TOMEY PE-300 PORTABLE ERG | 1992-07-15 | 91 |
| K841293 | Keller Instruments, Inc. | PANORAMIC LOUPES - VARIOUS | 1984-05-09 | 41 |
| K781543 | Sonometrics Systems, Inc. | ORBIOGRAPH | 1978-10-24 | 46 |
Recalls for HLT devices
openFDA lists no recalls for product code HLT.
Frequently asked questions
What is FDA product code HLT?
HLT is the FDA product code for preamplifier, ac-powered, ophthalmic. It is a Class II device, regulated under 21 CFR 886.1640 and reviewed by the Ophthalmic panel.
What device class is HLT?
Class II, regulation 21 CFR 886.1640. Typical premarket route: 510(k).
How long does a 510(k) take for product code HLT?
Across 4 cleared submissions the average was 253 days from receipt to decision (median 68).
Which companies have the most HLT clearances?
Chalgren Enterprises, Inc. (1); Tomey Corporation USA (1); Keller Instruments, Inc. (1); Sonometrics Systems, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HLT
- Run a recall and safety report across every HLT manufacturer
- Watch product code HLT 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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