Photokeratoscope
The Photokeratoscope is an ophthalmic diagnostic device that uses concentric ring patterns and photography to measure and record the curvature and regularity of the corneal surface. It is classified as FDA Class 1, representing the lowest risk level, subject only to general controls without a premarket submission requirement. The product code is HJA, regulated under 21 CFR 886.1350, within the Ophthalmic medical specialty. No special risk flags apply to this device.
Basic Information
- Product Code
- HJA
- Device Class
- FDA class 1
- Regulation Number
- 886.1350
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K901523 | VKG 1000, VIDEO KERATOGRAPH | Jun 27, 1990 | Substantially Equivalent | THE SANBORN CO. |
| K893968 | VKG 2000 VIDEO KERATOMETER | Sep 11, 1989 | Substantially Equivalent | TECHNITEX, INC. |
| K842128 | AMERICAN MEDICAL OPTICS PHOTOKERATO | Aug 07, 1984 | Substantially Equivalent | AMERICAN MEDICAL OPTICS |
| K830290 | DORC CONTACT/PHOTO DERATOSCOPE | Mar 09, 1983 | Substantially Equivalent | JEDMED INSTRUMENT CO. |
| K781650 | TERRY KERATOMETER | Oct 17, 1978 | Substantially Equivalent | CLIFFORD M. TERRY, M.C. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.