HJF — Magnifier, Hand-Held, Low-Vision Class I
FDA product code HJF covers "Magnifier, Hand-Held, Low-Vision", a Class I medical device regulated under 21 CFR 886.5540. Submissions are reviewed by the Ophthalmic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- HJF
- Device Class
- Class I
- Regulation Number
- 886.5540
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K820375 | gazelle | PLASTIC OR GLASS MAGNIFIER | June 14, 1982 |