Set, Lens, Trial, Ophthalmic
An Ophthalmic Trial Lens Set is a collection of lenses in various spherical, cylindrical, and prismatic powers used with a trial frame during refraction examinations to subjectively determine a patient's corrective prescription. This device is FDA Class 1 (lowest risk), subject to general controls only without requiring premarket notification or approval. It carries product code HPC and is regulated under 21 CFR 886.1405, within the Ophthalmic medical specialty.
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Basic Information
- Product Code
- HPC
- Device Class
- FDA class 1
- Regulation Number
- 886.1405
- 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 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K945443 | BOBES LENS SET | Jul 19, 1995 | Substantially Equivalent | Bobes S.A. |
| K951437 | OTI MODEL TLS-60 | Apr 11, 1995 | Substantially Equivalent | Oti Medical, LLC |
| K930195 | OPHTHALMIC TRIAL LENSES | Jan 06, 1994 | Substantially Equivalent | Optimark Accessories and Instruments |
| K934859 | CONTACT LENSES | Dec 21, 1993 | Substantially Equivalent | Arno Intl., Inc. |
| K930446 | MARCO TRIAL SETS | Jul 06, 1993 | Substantially Equivalent | Marco Ophthalmic, Inc. |
| K924786 | BURTON TRIAL LENS SET | Apr 14, 1993 | Substantially Equivalent | R.H. Burton Co. |
| K920571 | TRIAL LENS SET | May 07, 1992 | Substantially Equivalent | R.H. Burton Co. |
| K900478 | WOODLYN FULL APERTURE TRIAL LENS SET | Feb 21, 1990 | Substantially Equivalent | Woodlyn, Inc. |
| K873907 | CONFIRMATION TESTS | Dec 29, 1987 | Substantially Equivalent | Richmond Products, Inc. |
| K852056 | ACC CROSS CYLINDERS | Jun 05, 1985 | Substantially Equivalent | Ascon Medical Instruments, Ltd. |
| K843095 | TRIA LENS SET | Oct 05, 1984 | Substantially Equivalent | Optek Medico Co., Ltd. |
| K841766 | WOODLYN CLASSIC TRIAL LENS SET | Jun 01, 1984 | Substantially Equivalent | Woodlyn, Inc. |
| K770389 | LENS SET, MENTOR TRIAL | Mar 14, 1977 | Substantially Equivalent | Codman & Shurtleff, Inc. |
FEI Numbers
This FDA classification entry is associated with 56 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 56 registration numbers. Click on an entry to view related FDA registrations.