HJA — Photokeratoscope Class I
FDA product code HJA covers "Photokeratoscope", a Class I medical device regulated under 21 CFR 886.1350. Submissions are reviewed by the Ophthalmic panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- HJA
- 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 |
|---|---|---|---|
| K901523 | Sanborn | VKG 1000, VIDEO KERATOGRAPH | Jun 27, 1990 |
| K893968 | Technitex | VKG 2000 VIDEO KERATOMETER | Sep 11, 1989 |
| K842128 | American Medical Optics | AMERICAN MEDICAL OPTICS PHOTOKERATO | Aug 7, 1984 |
| K830290 | Jedmed Instrument | DORC CONTACT/PHOTO DERATOSCOPE | Mar 9, 1983 |
| K781650 | Clifford M. Terry, M.C | TERRY KERATOMETER | Oct 17, 1978 |