Contact Laser & Diagnostic Lenses
FDA 510(k) K023221 · Volk Optical, Inc.
510(k) numberK023221
Submission
- Device name
- Contact Laser & Diagnostic Lenses
- Applicant
- Volk Optical, Inc.
Rockville, MD, US - Received
- September 27, 2002
- Decision date
- October 11, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HJK – Lens, Contact, Polymethylmethacrylate, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1385
- Specialty
- Ophthalmic
Other 510(k)s with product code HJK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K201909 | RxSight Contact LensHJK · Traditional | Rxsight, Inc. | 09/10/2020SE |
| K173944 | Endocular Viewing Lenses and Silicone RingHJK · Traditional | Phakos | 10/25/2018SE |
| K151961 | Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy LensHJK · Special | Volk Optical, Inc. | 08/18/2015SE |
| K142715 | Sensor Medical Family of Vitrectomy Lenses and ProductsHJK · Traditional | Sensor Medical Technology, LLC | 12/16/2014SE |
| K051630 | Super View Disposable Biom Lens SetHJK · Traditional | Insight Instruments, Inc. | 06/29/2005SE |
| K051103 | Haag-Streit Contact Glasses Stery Cup, AccessoryHJK · Traditional | Haag-Streit USA, Inc. | 06/07/2005SE |
| K050623 | Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D, Volk 45 Prism…HJK · Special | Volk Optical, Inc. | 03/28/2005SE |
| K033950 | Dorc Vitrectomy Lenses, Model 1284 SeriesHJK · Traditional | Dutch Ophthalmic Research Center (D.O.R.C.) | 02/20/2004SE |
| K030054 | Disposable Vitrectomy Sets, Disposable Virectomy LensesHJK · Traditional | Fci Ophthalmics, Inc. | 02/26/2003SE |
| K022413 | Luneau 3 Mirror LensHJK · Traditional | Luneau SA | 09/24/2002SE |
More from Luneau SA
| 510(k) | Device | Decision |
|---|---|---|
| K151961 | Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy LensHJK · Special | 08/18/2015SE |
| K050623 | Volk Disposable Vitrectomy Lenses, Models Volk Flat SSV D, Volk Afx SSV D, Volk 45 Prism…HJK · Special | 03/28/2005SE |
| K943125 | Quadraspheric Fundus LensHJK · Traditional | 09/02/1994SE |
Questions and answers
When was Contact Laser & Diagnostic Lenses cleared by the FDA?
Contact Laser & Diagnostic Lenses (K023221) received a 510(k) decision of Substantially Equivalent on October 11, 2002, 14 days after the submission was received.
What is the product code of K023221?
The FDA product code is HJK – Lens, Contact, Polymethylmethacrylate, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 886.1385.