Nidek Digital Keratometer
FDA 510(k) K842892 · Nidek, Inc.
510(k) numberK842892
Submission
- Device name
- Nidek Digital Keratometer
- Applicant
- Nidek, Inc.
Walker, MI, US - Received
- July 23, 1984
- Decision date
- October 5, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HQL – Intraocular Lens
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 886.3600
- Specialty
- Ophthalmic
- Implant
- Yes
Other 510(k)s with product code HQL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K914311 | Chiroflex II Lens Microsert(Tm)HQL · Traditional | Chiron Ophthalmics | 01/27/1992SE |
| K913626 | Softrans InjectorHQL · Traditional | Staar Surgical Co. | 12/18/1991SE |
| K842504 | Amer. Medical Optics Digital Kerato-HQL · Traditional | American Medical Optics | 10/01/1984SE |
| K771933 | Cilco Anterior Chamber LensHQL · Traditional | California Intraocular Lens | 01/26/1978SE |
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| K152603 | Green Laser Photocoagulator GYC-500HQF · Traditional | 05/02/2016SE |
Questions and answers
When was Nidek Digital Keratometer cleared by the FDA?
Nidek Digital Keratometer (K842892) received a 510(k) decision of Substantially Equivalent on October 5, 1984, 74 days after the submission was received.
What is the product code of K842892?
The FDA product code is HQL – Intraocular Lens, a Class III (high risk) device regulated under 21 CFR 886.3600.