FDA product code HLW: Preamplifier, Battery-Powered, Ophthalmic
HLW is the FDA product code for preamplifier, battery-powered, ophthalmic. It is a Class II device, regulated under 21 CFR 886.1640 and reviewed by the Ophthalmic panel. FDA has cleared 3 510(k) submissions under HLW. The average 510(k) review took 46 days (median 32).
Classification
| Field | Value |
|---|---|
| Device name | Preamplifier, Battery-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 HLW clearance
Top HLW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Oculinum, Inc. | 3 | 1990-02-09 |
Most recent HLW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K900098 | Oculinum, Inc. | MONOPOLAR NEEDLE ELECTRODE | 1990-02-09 | 32 |
| K900279 | Oculinum, Inc. | OCULINUM INJECTION AMPLIFIER | 1990-02-09 | 32 |
| K854793 | Oculinum, Inc. | MONOPOLAR INJECTION NEEDLE ELECTRODE | 1986-02-18 | 75 |
Recalls for HLW devices
openFDA lists no recalls for product code HLW.
Frequently asked questions
What is FDA product code HLW?
HLW is the FDA product code for preamplifier, battery-powered, ophthalmic. It is a Class II device, regulated under 21 CFR 886.1640 and reviewed by the Ophthalmic panel.
What device class is HLW?
Class II, regulation 21 CFR 886.1640. Typical premarket route: 510(k).
How long does a 510(k) take for product code HLW?
Across 3 cleared submissions the average was 46 days from receipt to decision (median 32).
Which companies have the most HLW clearances?
Oculinum, Inc. (3).
Next steps
- Run an FDA pathway report with predicate devices for product code HLW
- Run a recall and safety report across every HLW manufacturer
- Watch product code HLW 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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