Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart F — Therapeutic Devices](/submissions/OP/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 886.5925](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5925) → LPM — Lenses, Soft Contact, Extended Wear # LPM · Lenses, Soft Contact, Extended Wear _Ophthalmic · 21 CFR 886.5925 · Class 3_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPM ## Overview - **Product Code:** LPM - **Device Name:** Lenses, Soft Contact, Extended Wear - **Regulation:** [21 CFR 886.5925](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/886.5925) - **Device Class:** 3 - **Review Panel:** [Ophthalmic](/submissions/OP) ## Identification A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water. ## Classification Rationale (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear. ## Recent Cleared Devices (20 of 37) Showing 20 most recent of 37 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [P220007](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPM/P220007.md) | Precision7™; Precision7™ for Astigmatism; Precision7™ Multifocal; Precision7™ Multifocal Toric (serafilcon A) Soft Conta | Alcon Laboratories, Inc. | Apr 25, 2023 | APPR | | [P170035](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPM/P170035.md) | Bausch + Lomb Ultra (samfilcon A) Contact Lenses | Bausch and Lomb, Inc., | Apr 30, 2018 | APPR | | [P080011](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPM/P080011.md) | BIOFINITY (COMFILCON A) | CooperVision, Inc. | Nov 19, 2008 | APPR | | [P040045](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPM/P040045.md) | VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER | Vistakon, Division of Johnson & Johnson Vision Car | Dec 20, 2005 | APPR | | [P000030](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPM/P000030.md) | FOCUS NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES | Alcon Laboratories, Inc. | Oct 12, 2001 | APPR | | [P010019](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPM/P010019.md) | FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES | Alcon Laboratories, Inc. | Oct 11, 2001 | APPR | | [P990085](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPM/P990085.md) | VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER | Johnson & Johnson Vision Care, Inc. | Feb 16, 2001 | APWD | | [P990072](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPM/P990072.md) | W-55 (METHAFILCON A) AND HORIZON 55 SOFT EXTENDED WEAR CONTACT LENSES | Westcon Contact Lens Co., Inc. | Aug 22, 2000 | APWD | | [P980006](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPM/P980006.md) | PURE VISION VISIBILITY TINTED CONTACT LENS FOR EXTENDED WEAR | Bausch & Lomb, Inc. | Feb 5, 1999 | APPR | | [P960039](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPM/P960039.md) | SOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR) | Unilens Corporation, USA | Apr 17, 1997 | APWD | | [P960022](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPM/P960022.md) | SOFLENS66(TM) | Bausch & Lomb, Inc. | Dec 16, 1996 | APPR | | [P940013](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPM/P940013.md) | PRECISION(TM) UV (VASURFILCON) | Alcon Laboratories, Inc. | Sep 30, 1994 | APWD | | [P890049](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPM/P890049.md) | FINISHED METHAFILCON A CONTACT LENSES | Lombart Lenses, Ltd. | Sep 28, 1989 | APWD | | [P890040](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPM/P890040.md) | SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC LENS | Unilens Corp., USA | Sep 28, 1989 | APPR | | [P890023](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPM/P890023.md) | H55 HYDROPHILIC CONTACT LENS | The Cooper Companies | Sep 19, 1989 | APPR | | [P880029](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPM/P880029.md) | B AND L 70 LIDOFILCON A CONTACT LENSE | Bausch & Lomb, Inc. | Apr 29, 1988 | APWD | | [P860040](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPM/P860040.md) | SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES | Wavetouch Technologies, LLC | Feb 19, 1987 | APPR | | [P850079](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPM/P850079.md) | HYDRASOFT (METHAFILCON B) CONTACT LENS | CooperVision, Inc. | Jan 31, 1986 | APPR | | [P850078](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPM/P850078.md) | KONTUR 55 EW | Kontur Kontact Lens Co., Inc. | Jan 31, 1986 | APWD | | [P850077](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPM/P850077.md) | SUNSOFT (METHAFILOCN A) HYDROPHILIC CONTACT LENS | CooperVision, Inc. | Jan 31, 1986 | APWD | ## Top Applicants - Alcon Laboratories, Inc. — 6 clearances - Bausch & Lomb, Inc. — 6 clearances - CooperVision, Inc. — 6 clearances - Advanced Medical Optics, Inc. — 2 clearances - Ciba Vision Care — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPM](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPM) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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