HLW
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Preamplifier, Battery-Powered, Ophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1640
- Medical specialty
- Ophthalmic
- Flags
- Third-party review eligible
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| Record | Firm | Date | Builder |
|---|---|---|---|
| MONOPOLAR NEEDLE ELECTRODE (K900098) | Oculinum, Inc. | 1990-02-09 | + Add |
| OCULINUM INJECTION AMPLIFIER (K900279) | Oculinum, Inc. | 1990-02-09 | + Add |
| MONOPOLAR INJECTION NEEDLE ELECTRODE (K854793) | Oculinum, Inc. | 1986-02-18 | + Add |
Track HLW automatically
Every clearance here is in the API, with alerts when new ones post.