HLR — Keratoscope, Battery-Powered Class I
FDA product code HLR covers "Keratoscope, Battery-Powered", a Class I medical device regulated under 21 CFR 886.1350. Submissions are reviewed by the Ophthalmic panel. At least 7 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- HLR
- Device Class
- Class I
- Regulation Number
- 886.1350
- Submission Type
- 510(k) Exempt
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K901553 | Sanborn | SURG-K SURGICAL KERATOMETER | Jul 20, 1990 |
| K882902 | Technitex | QRK 100, QUALITATIVE RING KERATOSCOPE | Aug 4, 1988 |
| K882618 | Gamut Ent | JEDMED/POLACK KERATOSCOPE HS/SL | Jul 13, 1988 |
| K864639 | Jedmed Instrument | REUSABLE SURGICAL KERATOSCOPE | Dec 29, 1986 |
| K854054 | Cutler Medical Instruments | PLACIDO DISC | Dec 27, 1985 |
| K830008 | Surgidev | KARICKHOFF KERATOSCOPE | Jan 26, 1983 |
| K821080 | Medical Equipment Designs | HAND KERATOSCOPE | May 24, 1982 |