Keratoscope, Battery-Powered
The Battery-Powered Keratoscope is a portable ophthalmic instrument that projects a ring or disc pattern onto the corneal surface to assess its curvature and regularity, useful in detecting corneal irregularities such as keratoconus. It is classified as FDA Class 1, the lowest risk level, subject only to general controls without any premarket notification submission. The product code is HLR, regulated under 21 CFR 886.1350, within the Ophthalmic medical specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements under 21 CFR Part 820.
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Basic Information
- Product Code
- HLR
- 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 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K901553 | SURG-K SURGICAL KERATOMETER | Jul 20, 1990 | Substantially Equivalent | The Sanborn Co. |
| K882902 | QRK 100, QUALITATIVE RING KERATOSCOPE | Aug 04, 1988 | Substantially Equivalent | Technitex, Inc. |
| K882618 | JEDMED/POLACK KERATOSCOPE HS/SL | Jul 13, 1988 | Substantially Equivalent | Gamut Ent. |
| K864639 | REUSABLE SURGICAL KERATOSCOPE | Dec 29, 1986 | Substantially Equivalent | Jedmed Instrument Co. |
| K854054 | PLACIDO DISC | Dec 27, 1985 | Substantially Equivalent | Cutler Medical Instruments |
| K830008 | KARICKHOFF KERATOSCOPE | Jan 26, 1983 | Substantially Equivalent | Surgidev Corp. |
| K821080 | HAND KERATOSCOPE | May 24, 1982 | Substantially Equivalent | Medical Equipment Designs, Inc. |
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.