510(k) · Cleared

Cleared

Rigid Gas Permeable Contact Lens

K000795510(k) TraditionalCleared May 26, 200074-day reviewClass II21 CFR 886.5916

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Polymer Technology · HQD Lens, Contact (Other Material) - Daily

Cleared on May 26, 2000 as substantially equivalent to K943177 (Polymer Technology Corp., 1994) after a 74-day review. Its family tree reaches back 1 generation to 1994. 50 later devices descend from it.

Decided: May 26, 2000
Review: 74 days
Class: Class II
Product code: HQD
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K943177 (1994). 50 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 1 generation backK943177 Boston (R) 7 - 30(Enflufocon a)Polymer Technology Corp. · 1994 · Recalled
This deviceK000795 Rigid Gas Permeable Contact LensPolymer Technology · 2000
Descendant · cites it directly · 39 of its ownK020006 Dyna Intra-Limbal LensLens Dynamics, Inc. · 2002
Descendant · 2 generations on · 38 of its ownK053124 Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO…Bausch & Lomb, Incorporated · 2006
Descendant · cites it directly · 28 of its ownK033594 Optimum GP (Oxygen Permeable) Daily Wear Contact LensesContamac, Ltd. · 2004 · Recalled
Descendant · cites it directly · 26 of its ownK071266 Boston X02 (Hexafocon B) Rigid Gas Permeable Contact LensBausch & Lomb, Inc. · 2007 · Recalled
Descendant · 2 generations on · 20 of its ownK153066 BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight · 2016

Showing 5 of 50 descendants. See all descendants

Descendants cleared per year

2002high 7 (2016) · low 0 (2010)2026

Most influential descendants

Showing 5 of 50 · See all

K020006Dyna Intra-Limbal LensLens Dynamics, Inc. · 2002 · cites it directly39descendants
K053124Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a) Rigid Gas…Bausch & Lomb, Incorporated · 2006 · 2 generations on38descendants
K033594Optimum GP (Oxygen Permeable) Daily Wear Contact LensesContamac, Ltd. · 2004 · cites it directly28descendants
K071266Boston X02 (Hexafocon B) Rigid Gas Permeable Contact LensBausch & Lomb, Inc. · 2007 · cites it directly26descendants
K153066BostonSight IC Corneal Lens, BostonSight IC Scleral LensBoston Foundation For Sight · 2016 · 2 generations on20descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K943177	Boston (R) 7 - 30(Enflufocon a)	Polymer Technology Corp.	1994	1
0 (this device)	K000795	Rigid Gas Permeable Contact Lens	Polymer Technology	2000	—
+1	K020006	Dyna Intra-Limbal Lens	Lens Dynamics, Inc.	2002	—
+2	K053124	Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a)…	Bausch & Lomb, Incorporated	2006	—
+1	K033594	Optimum GP (Oxygen Permeable) Daily Wear Contact Lenses	Contamac, Ltd.	2004	2
+1	K071266	Boston X02 (Hexafocon B) Rigid Gas Permeable Contact Lens	Bausch & Lomb, Inc.	2007	2
+2	K153066	BostonSight IC Corneal Lens, BostonSight IC Scleral Lens	Boston Foundation For Sight	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2003	1	0
2004	1	0
2005	2	0
2006	3	0
2007	3	0
2008	1	0
2009	1	0
2011	2	0
2012	1	0
2014	1	0
2016	7	0
2017	4	0
2018	3	0
2019	2	0
2020	1	0
2021	3	0
2022	3	0
2023	3	0
2024	5	0
2026	1	0

FIG. 1 — Lineage of K000795, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K943177	Boston (R) 7 - 30(Enflufocon a) Summary page 3 …lens material is substantially equivalent to the currently marketed BOSTON ES contact lens material, which was cleared in 510(k) Premarket Notification No. K943177 on August 25, 1994. The difference between the two devices is a change in the components.…	Polymer Technology Corp.	1994	1

Also cleared against K943177: 5 other devices →

What descends from it? (50)

See all 50

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K020006	Dyna Intra-Limbal Lens	Lens Dynamics, Inc.	2002	39
K033594	Optimum GP (Oxygen Permeable) Daily Wear Contact Lenses	Contamac, Ltd.	2004	28
K071266	Boston X02 (Hexafocon B) Rigid Gas Permeable Contact Lens	Bausch & Lomb, Inc.	2007	26
K051035	Synergeyes (Paflucon D Hem-Iberfilcon a) Hybrid Contact Lens	Synergeyes	2005	5
K253822	GPA (hexafocon A) Rigid Gas Permeable Contact Lenses	Zhuhai Fitlens Medical Technology Co., Ltd.	2026	0
K032256	Quasar-Quasar Plus-Quasar Toric (Hybufocon a, Hexafocon a, Paflufocon B) Rigid Gas…	No 7 Contact Lens Laboratory, Ltd.	2003	0
K021752	FP (Hexafocon a)RGP Contact Lens Spherical/Asp (Hexafocon a)RGP Contact Lens Aspherical	Lucid Korea Co., Ltd.	2002	0

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?

Its one ancestor has a recall.
Of its descendants, K020006 (Lens Dynamics, Inc., 2002) has gone furthest, with 39 descendants of its own.
5 other devices also cite its predicate K943177.

How does its category compare?

All HQD devices

HQD Lens, Contact (Other Material) - Daily: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HQD

5in 2024

2007high 9 (2017) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HQD

80in 2024

2007high 123 (2021) · low 29 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HQD

1in 2010

2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HQD

2in 2025

2007high 26 (2014) · low 0 (2018)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?

BOSTON XO (hexafocon A) Contact Lens Material is indicated for daily wear for

the correction of refractive ametropia (myopia, hyperopia, astigmatism and

presbyopia) 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/K000795 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000795: Rigid Gas Permeable Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000795

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026