Product code HPC
- Device name
- Set, Lens, Trial, Ophthalmic
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.1405
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K945443 | BOBES LENS SET | Bobes S.A. | 1995-07-19 |
| K951437 | OTI MODEL TLS-60 | Oti Medical, LLC | 1995-04-11 |
| K930195 | OPHTHALMIC TRIAL LENSES | Optimark Accessories and Instruments | 1994-01-06 |
| K934859 | CONTACT LENSES | Arno Intl., Inc. | 1993-12-21 |
| K930446 | MARCO TRIAL SETS | Marco Ophthalmic, Inc. | 1993-07-06 |
| K924786 | BURTON TRIAL LENS SET | R.H. Burton Co. | 1993-04-14 |
| K920571 | TRIAL LENS SET | R.H. Burton Co. | 1992-05-07 |
| K900478 | WOODLYN FULL APERTURE TRIAL LENS SET | Woodlyn, Inc. | 1990-02-21 |
| K873907 | CONFIRMATION TESTS | Richmond Products, Inc. | 1987-12-29 |
| K852056 | ACC CROSS CYLINDERS | Ascon Medical Instruments, Ltd. | 1985-06-05 |
| K843095 | TRIA LENS SET | Optek Medico Co., Ltd. | 1984-10-05 |
| K841766 | WOODLYN CLASSIC TRIAL LENS SET | Woodlyn, Inc. | 1984-06-01 |
| K770389 | LENS SET, MENTOR TRIAL | Codman & Shurtleff, Inc. | 1977-03-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B945BC127680 | Bernell | Bernell | 2026-05-03 |
| B945TLRCM1500 | Bernell | Bernell | 2026-05-02 |
| B945TLRCM5000 | Bernell | Bernell | 2026-05-02 |
| B945TLRCM4750 | Bernell | Bernell | 2026-05-02 |
| B945TLRCM4500 | Bernell | Bernell | 2026-05-02 |
| B945TLRCM4250 | Bernell | Bernell | 2026-05-02 |
| B945TLRCM4000 | Bernell | Bernell | 2026-05-02 |
| B945TLRCM3750 | Bernell | Bernell | 2026-05-02 |
| B945TLRCM3500 | Bernell | Bernell | 2026-05-02 |
| B945TLRCM3250 | Bernell | Bernell | 2026-05-02 |
| B945TLRCM3000 | Bernell | Bernell | 2026-05-02 |
| B945TLRCM2750 | Bernell | Bernell | 2026-05-02 |
| B945TLRCM2500 | Bernell | Bernell | 2026-05-02 |
| B945TLRCM2250 | Bernell | Bernell | 2026-05-02 |
| B945TLRCM2000 | Bernell | Bernell | 2026-05-02 |
| B945TLRCM1750 | Bernell | Bernell | 2026-05-02 |
| B945TLRCM1250 | Bernell | Bernell | 2026-05-02 |
| B945TLRCM1000 | Bernell | Bernell | 2026-05-02 |
| B945TLRCM0750 | Bernell | Bernell | 2026-05-02 |
| B945TLRCM0500 | Bernell | Bernell | 2026-05-02 |
| B945TLRCM0370 | Bernell | Bernell | 2026-05-02 |
| B945TLRCM0250 | Bernell | Bernell | 2026-05-02 |
| B945TLRCM0120 | Bernell | Bernell | 2026-05-02 |
| B945TLRBCR0 | Bernell | Bernell | 2026-05-02 |
| B945TLRBCG0 | Bernell | Bernell | 2026-05-02 |
| B945LENS65M3000 | Bernell | Bernell | 2026-05-02 |
| B945CNS68L0 | Bernell | Bernell | 2026-05-02 |
| B945CNS266KIT0 | Bernell | Bernell | 2026-05-02 |
| B945CNS2660 | Bernell | Bernell | 2026-05-02 |
| B945CNS232A0 | Bernell | Bernell | 2026-05-02 |