510(k) · Cleared
ClearedGPA (hexafocon A) Rigid Gas Permeable Contact Lenses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhuhai Fitlens Medical Technology Co., Ltd. · HQD Lens, Contact (Other Material) - Daily
Cleared on Mar 27, 2026 as substantially equivalent to K000795 (Polymer Technology, 2000) and 1 other predicate after a 119-day review. Its family tree reaches back 8 generations to 1994.
- Decided
- Mar 27, 2026
- Review
- 119 days
- Class
- Class II
- Product code
- HQD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K943177 (1994). 20 ancestors in all, the oldest P860022 (1987). No later device cites it as a predicate yet.
- Root · 8 generations backK943177 Boston (R) 7 - 30(Enflufocon a)Polymer Technology Corp. · 1994 · Recalled
- 7 generations backK000795 Rigid Gas Permeable Contact LensPolymer Technology · 2000
- 6 generations backK020006 Dyna Intra-Limbal LensLens Dynamics, Inc. · 2002
- 5 generations backK053124 Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO…Bausch & Lomb, Incorporated · 2006
- 4 generations backK071266 Boston X02 (Hexafocon B) Rigid Gas Permeable Contact LensBausch & Lomb, Inc. · 2007 · Recalled
- 3 generations backK153066 BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight · 2016
- 2 generations backK161461 BostonSight PD Prosthetic DeviceBostonsight · 2016 · Recalled
- 1 generation backK171404 BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Bausch + Lomb, Incorporated · 2017
- This deviceK253822 GPA (hexafocon A) Rigid Gas Permeable Contact LensesZhuhai Fitlens Medical Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K943177 | Boston (R) 7 - 30(Enflufocon a) | Polymer Technology Corp. | 1994 | 1 |
| −7 | K000795 | Rigid Gas Permeable Contact Lens | Polymer Technology | 2000 | — |
| −6 | K020006 | Dyna Intra-Limbal Lens | Lens Dynamics, Inc. | 2002 | — |
| −5 | K053124 | Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a)… | Bausch & Lomb, Incorporated | 2006 | — |
| −4 | K071266 | Boston X02 (Hexafocon B) Rigid Gas Permeable Contact Lens | Bausch & Lomb, Inc. | 2007 | 2 |
| −3 | K153066 | BostonSight IC Corneal Lens, BostonSight IC Scleral Lens | Boston Foundation For Sight | 2016 | — |
| −2 | K161461 | BostonSight PD Prosthetic Device | Bostonsight | 2016 | 1 |
| −1 | K171404 | BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) | Bausch + Lomb, Incorporated | 2017 | — |
| 0 (this device) | K253822 | GPA (hexafocon A) Rigid Gas Permeable Contact Lenses | Zhuhai Fitlens Medical Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 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 LensSummary page 6…quivalent to the following predicate devices: ▪ “RIGID GAS PERMEABLE CONTACT LENS” By POLYMER TECHNOLOGY 510(k) number; K000795 Product Code: HQD ▪ “Boston XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable C… | 2000 |
| * | K171404 | BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)Summary page 6…XO® (hexafocon A) and Boston XO2® (hexafocon B) Rigid Gas Permeable Contact Lens” By Bausch + Lomb Inc. 510(k) number; K171404 Product Code: HQD IV. DEVICE DESCRIPTION The GPA (hexafocon A) Rigid Gas Permeable Contact Lenses are la… | 2017 |
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?
- The line of descent spans 32 years and passes through 9 companies; a new generation was cleared every 3.8 years on median.
- 4 of the 20 ancestors have 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. 2026, this device’s year, is highlighted.
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?
The GPA (hexafocon A) Rigid Gas Permeable Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 0.75 diopters. The GPA-AT (hexafocon A) Rigid Gas Permeable Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes…
Read the full statement (263 words)
The GPA (hexafocon A) Rigid Gas Permeable Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 0.75 diopters.
The GPA-AT (hexafocon A) Rigid Gas Permeable Contact Lens is indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 6.00 diopters.
The GPA-M, GPA-PN and GPA-PD (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 0.75 diopters.
The GPA-PDT, GPA-MT, and GPA-PNT (hexafocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 6.00 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The GPA-K (hexafocon A) Rigid Gas Permeable Contact Lens may be prescribed in otherwise non-diseased eyes that require a rigid gas permeable lens for the management of irregular corneal conditions such as; keratoconus, pellucid marginal degeneration or following penetrating keratoplasty or refractive (e.g. LASIK) surgery.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253822 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253822: GPA (hexafocon A) Rigid Gas Permeable Contact Lenses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253822
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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