HPC · Set, Lens, Trial, Ophthalmic
Ophthalmic · 21 CFR 886.1405 · Class 1
Overview
| Product Code | HPC |
|---|---|
| Device Name | Set, Lens, Trial, Ophthalmic |
| Regulation | 21 CFR 886.1405 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
An ophthalmic trial lens set is a device that is a set of lenses of various dioptric powers intended to be handheld or inserted in a trial frame for vision testing to determine refraction.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.
Cleared Devices (13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K945443 | BOBES LENS SET | Bobes S.A. | Jul 19, 1995 | SESE |
| K951437 | OTI MODEL TLS-60 | Oti Medical, LLC | Apr 11, 1995 | SESE |
| K930195 | OPHTHALMIC TRIAL LENSES | Optimark Accessories and Instruments | Jan 6, 1994 | SESE |
| K934859 | CONTACT LENSES | Arno Intl., Inc. | Dec 21, 1993 | SESE |
| K930446 | MARCO TRIAL SETS | Marco Ophthalmic, Inc. | Jul 6, 1993 | SESE |
| K924786 | BURTON TRIAL LENS SET | R.H. Burton Co. | Apr 14, 1993 | SESE |
| K920571 | TRIAL LENS SET | R.H. Burton Co. | May 7, 1992 | SESE |
| K900478 | WOODLYN FULL APERTURE TRIAL LENS SET | Woodlyn, Inc. | Feb 21, 1990 | SESE |
| K873907 | CONFIRMATION TESTS | Richmond Products, Inc. | Dec 29, 1987 | SESE |
| K852056 | ACC CROSS CYLINDERS | Ascon Medical Instruments, Ltd. | Jun 5, 1985 | SESE |
| K843095 | TRIA LENS SET | Optek Medico Co., Ltd. | Oct 5, 1984 | SESE |
| K841766 | WOODLYN CLASSIC TRIAL LENS SET | Woodlyn, Inc. | Jun 1, 1984 | SESE |
| K770389 | LENS SET, MENTOR TRIAL | Codman & Shurtleff, Inc. | Mar 14, 1977 | SESE |
Top Applicants
- Woodlyn, Inc. — 2 clearances
- R.H. Burton Co. — 2 clearances
- Richmond Products, Inc. — 1 clearance
- Oti Medical, LLC — 1 clearance
- Optimark Accessories and Instruments — 1 clearance
