Product code HOE
- Device name
- Caliper, Ophthalmic
- Medical specialty
- Ophthalmic
- Device class
- 1
- Regulation number
- 886.4350
- 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 |
|---|---|---|---|
| K881094 | KOI(TM) BLADE GAUGE, MODEL KOI-132 | CooperVision, Inc. | 1988-04-01 |
| K813315 | CALIPER-OPTHALMIC | Design Research Assoc., Inc. | 1982-03-01 |
| K820050 | KREMER BLADE GAUGE | Accutome, Inc. | 1982-02-24 |
| K812011 | BLADE GAUGE | Koi, Inc. | 1981-07-28 |
| K801937 | BLEPHAROMETER | Aztec Medical Products, Inc. | 1980-09-16 |
| K792383 | KELMAN DIPSTICK | V. Mueller O.V. Baxter Healthcare Corp. | 1979-12-11 |
| K781715 | RULER, WECK SCOTT | Edward Weck, Inc. | 1978-12-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04251047924378 | Castroviejo Caliper | A1 Medical GmbH | 2026-05-29 |
| G412PH64390 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH94010 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH9400T0 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH94000 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH9362T0 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH93620 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH9361T0 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH93610 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH658410 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH65840 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH65830 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH65820 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH658110 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH65810 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH65800 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH64360 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH64350 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH6434R0 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH6434L0 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH6433R0 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH6433L0 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH62560 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH62550 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH62540 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH62520 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH62510 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH62500 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH61270 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |
| G412PH20330 | MR PHACO | Crestpoint Management Limited | 2025-05-27 |