510(k) · Cleared
ClearedFluoroperm 92, 60, 30 and 151 and Paragon HDS, HDS 100 and Thin 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 May 1, 2007 after a 55-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- May 1, 2007
- Review
- 55 days
- Class
- Class II
- Product code
- HQD
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK070637 Fluoroperm 92, 60, 30 and 151 and Paragon HDS, HDS 100 and Thin…Paragon Vision Sciences · 2007
- Descendant · cites it directly · 1 of its ownK120996 Fluoroperm 30 Paragon HDS Fluoroperm 60 Paragon HDS 100 Fluoroperm…Paragon Vision Sciences · 2012
- Descendant · 2 generations on · 0 of its ownK180172 FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with…Paragon Vision Sciences · 2018
Most influential descendants
Showing 2 of 2 · See all- K120996Fluoroperm 30 Paragon HDS Fluoroperm 60 Paragon HDS 100 Fluoroperm 92 Fluoroperm 151…Paragon Vision Sciences · 2012 · cites it directly1descendant
- K180172FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG…Paragon Vision Sciences · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070637 | Fluoroperm 92, 60, 30 and 151 and Paragon HDS, HDS 100 and Thin Rigid Gas… | Paragon Vision Sciences | 2007 | — |
| +1 | K120996 | Fluoroperm 30 Paragon HDS Fluoroperm 60 Paragon HDS 100 Fluoroperm 92… | Paragon Vision Sciences | 2012 | — |
| +2 | K180172 | FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible… | Paragon Vision Sciences | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 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? (3)
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 |
|---|---|---|---|
| * | — | Boston™ XO™ (hexafocon A) Named without a submission number | |
| * | — | Boston EO® (enflufocon B) Named without a submission number | |
| * | — | Boston ES™ (enflufocon A) Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120996 | Fluoroperm 30 Paragon HDS Fluoroperm 60 Paragon HDS 100 Fluoroperm 92 Fluoroperm 151… | 2012 | 1 |
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?
- Of its descendants, K120996 (Paragon Vision Sciences, 2012) has gone furthest, with 1 descendant of its own.
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. 2007, 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?
FluoroPerm® 92 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 92 rigid gas permeable bifocal, or toric 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 (1,059 words)
FluoroPerm® 92 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 92 rigid gas permeable bifocal, or toric 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. 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.
FluoroPerm® 92 contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.
FluoroPerm® 60 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from 1 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 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 +4.00 D add power.
FluoroPerm® 60 contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.
Paragon HDS® rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from 1 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 corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. 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.
Paragon HDS® contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.
FluoroPerm® 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 that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. 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.
FluoroPerm® 30 contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.
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 corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon Thin™ toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon Thin™ bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.
Paragon Thin™ contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.
FluoroPerm® 151 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from 1 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.
FluoroPerm® 151 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® 151 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 151 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.
FluoroPerm® 151 contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.
Paragon HDS® 100 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and 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.
Paragon HDS® 100 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. Paragon HDS® 100 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS® 100 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.
Paragon HDS® 100 contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K070637 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070637: Fluoroperm 92, 60, 30 and 151 and Paragon HDS, HDS 100 and Thin 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/K070637
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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