510(k) · Cleared
ClearedFP (Hexafocon a)RGP Contact Lens Spherical/Asp (Hexafocon a)RGP Contact Lens Aspherical
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lucid Korea Co., Ltd. · HQD Lens, Contact (Other Material) - Daily
Cleared on Oct 11, 2002 as substantially equivalent to K000795 (Polymer Technology, 2000) and 1 other predicate after a 136-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Oct 11, 2002
- Review
- 136 days
- Class
- Class II
- Product code
- HQD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K984436 (1999). 4 ancestors in all, the oldest K943177 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK984436 PVS BasicsParagon Vision Sciences · 1999
- This deviceK021752 FP (Hexafocon a)RGP Contact Lens Spherical/Asp (Hexafocon a)RGP…Lucid Korea Co., Ltd. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K984436 | PVS Basics | Paragon Vision Sciences | 1999 | — |
| 0 (this device) | K021752 | FP (Hexafocon a)RGP Contact Lens Spherical/Asp (Hexafocon a)RGP Contact Lens… | Lucid Korea Co., Ltd. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HQD? 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 HQD device
- #1 K240618 Acuity 200™ (fluoroxyfocon A) Rigid Gas…score 19.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K000795 | Rigid Gas Permeable Contact Lens | 2000 |
| * | K984436 | PVS BasicsSummary page 1…cleared 510(k) Prernarket Notification No. KO00795 and PVS BASICS (paflufocon E) rigid gas permeable contact lenses, which was cleared 5 l O Q Premarket Notification No. K984436 Device Description FP(hexafocon A) RGP Contact Lens Spherical and ASP(hexafocon A) RGP Contact Lens Aspherical… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 3 ancestors has a recall of any class.
- 6 other devices also cite its predicate K000795.
How does its category compare?
All HQD devicesHQD Lens, Contact (Other Material) - Daily: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQD
5in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HQD
80in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQD
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQD
2in 2025
MAUDE reports naming product code HQD, 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 | 4 | 78 | 0 | 6 |
| 2008 | 5 | 100 | 0 | 8 |
| 2009 | 2 | — | 0 | 12 |
| 2010 | 0 | — | 1 | 2 |
| 2011 | 2 | — | 0 | 7 |
| 2012 | 2 | — | 0 | 10 |
| 2013 | 0 | — | 0 | 15 |
| 2014 | 1 | — | 0 | 26 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 7 | 119 | 0 | 1 |
| 2017 | 9 | 66 | 0 | 3 |
| 2018 | 5 | 53 | 0 | 0 |
| 2019 | 2 | — | 0 | 5 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 3 | 123 | 0 | 3 |
| 2022 | 3 | 29 | 0 | 3 |
| 2023 | 3 | 77 | 0 | 8 |
| 2024 | 5 | 80 | 0 | 3 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
FP(hexafocon A) and ASP(hexafocon A) RGP Contact Lens are indicated for daily wear for the correction of refractive amptropia (myopia, hyperopia, astigmatism) in aphakic and not- aphakic persons with nondiseased eyes. The lens may be disinfected using a chemical disinfecting system only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021752 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021752: FP (Hexafocon a)RGP Contact Lens Spherical/Asp (Hexafocon a)RGP Contact Lens Aspherical.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021752
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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