510(k) · Cleared
ClearedFluoroperm 151 (Paflufocon D) and Paragon HDS 100 (Paflufocon D) Rigid Gas Permeable Contact Lenses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paragon Vision Sciences · HQD Lens, Contact (Other Material) - Daily
Cleared on Feb 10, 2006 after a 109-day review; its predicate, P820065, is listed below.
- Decided
- Feb 10, 2006
- Review
- 109 days
- Class
- Class II
- Product code
- HQD
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
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? (1)
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 |
|---|---|---|---|
| * | P820065 | Boston Lens (R) Lens - Clear FDA lists this PMA only through its supplements; the earliest we hold is P820065/S001 (Dec 23, 1983). Summary page 1…(itafocon A) rigid gas permeable contact lens in keratoconus lens designs approved in PMA P820065. on 11/17/1983 Device Description Keratoconus contact lens designs are available a… |
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 other device also cites its predicate P820065.
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?
FluoroPerm® 92 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from I to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 92 rigid gas pernicale bifocal, or ltric contact lenses are indicated for daily wear only. FluoroPerm® 92 rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual…
Read the full statement (978 words)
FluoroPerm® 92 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from I to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 92 rigid gas pernicale bifocal, or ltric contact lenses are indicated for daily wear only.
FluoroPerm® 92 rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPermn92 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. FluoroPerm® 92 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm ® 92 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.
FluoroPerm ® 60 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from I to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 60 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.
FluoroPerm ® 60 rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm ® 60 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. FluoroPerm ®60 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 60 bifocal lenses are indicated to treat presbyopia up to 14.00 [ add power.
Paragon HDS ® rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from I to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. Paragon HDS ® rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.
Paragon HDS® rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit comeal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS ® contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. Paragon HDS ® toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS" bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.
FluoroPermr 30 rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner.
FluoroPerm® 30 rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes thuF ire nearsighted (myopic), farsighted (hyperopic), and may exhibit comeal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 30 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes. FluoroPerm® 30 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm ® 30 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.
Paragon Thin" rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner.
Paragon Thin rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit comeal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon Thin T contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes. Paragon Thin T"toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon Thin MT bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.
FluoroPerm® 151 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from I to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 151 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.
Fluorol~erm~ 151]rigid gas permecab le spherical, aspheric and bifocal contact lenses are indicated for the correction of visualIacuity in not-aph akic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm" 15 1 contact lenses are indicated for persons requiring keratoconus managemrent with otherwise non-diseased eyes, daily wear application only. Fluorol~erm® 151 toric contact lenses are indicated to correct astigmatism up to 6.00 diopters. Fluorcopernn® 151 bifocal lenses are indicated to treat presbyopia up to 4+4.00 D add power.
Paragon FI)S®' 100 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from I to 7 days between removals for cleaning anid disinfection as recommended by the eye care practitioner-. Paragon HDS®" 100 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.
Parag-on HDS®~ 100 rigid gas permeable spherical, aspheric anid bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), anid may exhibit corneal astigmtatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HIDS" 100 contact lenses are indicated for persons requiring, keratoconus management with otherwise non-diseased eyes, daily wear application only. Paragon HOS® 100 toric contact lenses are indicated to correct astigmatism Of uip to 6.00 diopters. Paragon HDS®' 100 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052983 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052983: Fluoroperm 151 (Paflufocon D) and Paragon HDS 100 (Paflufocon D) Rigid Gas Permeable Contact Lenses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052983
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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