Frame, Trial, Ophthalmic
An Ophthalmic Trial Frame is an adjustable eyeglass frame used during refraction examinations to hold trial lenses in front of the patient's eyes, enabling the clinician to determine the optimal corrective lens prescription. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket submission. It carries product code HPA and is regulated under 21 CFR 886.1415, within the Ophthalmic medical specialty. It is exempt from Good Manufacturing Practice (GMP) requirements.
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Basic Information
- Product Code
- HPA
- Device Class
- FDA class 1
- Regulation Number
- 886.1415
- 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 |
|---|---|---|---|---|
| K852548 | ATL 225 MW TRAIL LENS SET | Jul 31, 1985 | Substantially Equivalent | Ascon Medical Instruments, Ltd. |
| K852126 | ATF 101 TRAIL FRAME | Jun 05, 1985 | Substantially Equivalent | Ascon Medical Instruments, Ltd. |
| K841768 | WOODLYN LIGHTWEIGHT TRIAL FRAME | Jun 01, 1984 | Substantially Equivalent | Woodlyn, Inc. |
| K833669 | IMAGE DEFLECTOR | Mar 27, 1984 | Substantially Equivalent | Michael Onufryk |
| K821084 | UNIVERSAL TRIAL FRAMEE | Jun 14, 1982 | Substantially Equivalent | Medical Equipment Designs, Inc. |
FEI Numbers
This FDA classification entry is associated with 59 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 59 registration numbers. Click on an entry to view related FDA registrations.