510(k) · Cleared
Recalled · Class III · 2015Contact Laser & Diagnostic Lenses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Volk Optical, Inc. · HJK Lens, Contact, Polymethylmethacrylate, Diagnostic
Cleared on Oct 11, 2002 after a 14-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it. It has been recalled once.
- Decided
- Oct 11, 2002
- Review
- 14 days
- Class
- Class II
- Product code
- HJK
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK023221 Contact Laser & Diagnostic LensesVolk Optical, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK151961 Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy LensVolk Optical, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK051103 Haag-Streit Contact Glasses Stery Cup, AccessoryHaag-Streit USA, Inc. · 2005
- Descendant · 2 generations on · 0 of its ownK173944 Endocular Viewing Lenses and Silicone RingPhakos · 2018
- Descendant · 2 generations on · 0 of its ownK052674 Contact Lens OphthalmodynamometerMeditron, GmbH · 2006
Most influential descendants
Showing 4 of 4 · See all- K151961Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy LensVolk Optical, Inc. · 2015 · cites it directly1descendant
- K051103Haag-Streit Contact Glasses Stery Cup, AccessoryHaag-Streit USA, Inc. · 2005 · cites it directly1descendant
- K173944Endocular Viewing Lenses and Silicone RingPhakos · 2018 · 2 generations on0descendants
- K052674Contact Lens OphthalmodynamometerMeditron, GmbH · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023221 | Contact Laser & Diagnostic Lenses | Volk Optical, Inc. | 2002 | — |
| +1 | K151961 | Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens | Volk Optical, Inc. | 2015 | — |
| +1 | K051103 | Haag-Streit Contact Glasses Stery Cup, Accessory | Haag-Streit USA, Inc. | 2005 | — |
| +2 | K173944 | Endocular Viewing Lenses and Silicone Ring | Phakos | 2018 | — |
| +2 | K052674 | Contact Lens Ophthalmodynamometer | Meditron, GmbH | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HJK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HJK device
- #1 K201909 RxSight Contact Lensscore -0.0 · 1 generation · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 27, 2015 | Class III | Z-1685-2015 | Process control | Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K151961 (Volk Optical, Inc., 2015) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HJK devicesHJK Lens, Contact, Polymethylmethacrylate, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HJK
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · HJK
Too few HJK 510(k)s in any year since 2007 to give a median.
Recalls per year · HJK
No recall names HJK since 2007.
Adverse event reports per year · HJK
1in 2025
MAUDE reports naming product code HJK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The device is indicated for use as a diagnostic contact lens for eye fundus examinations and use in the therapy of intraocular abnormalities.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K023221 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023221: Contact Laser & Diagnostic Lenses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023221
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026