LPM · Lenses, Soft Contact, Extended Wear
Ophthalmic · 21 CFR 886.5925 · Class 3
Overview
| Product Code | LPM |
|---|---|
| Device Name | Lenses, Soft Contact, Extended Wear |
| Regulation | 21 CFR 886.5925 |
| Device Class | Class 3 |
| Review Panel | Ophthalmic |
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 | Precision7; Precision7 for Astigmatism; Precision7 Multifocal; Precision7 Multifocal Toric (serafilcon A) Soft Conta | Alcon Laboratories, Inc. | Apr 25, 2023 | APPR |
| P170035 | Bausch + Lomb Ultra (samfilcon A) Contact Lenses | Bausch and Lomb, Inc., | Apr 30, 2018 | APPR |
| P080011 | BIOFINITY (COMFILCON A) | CooperVision, Inc. | Nov 19, 2008 | APPR |
| P040045 | VISTAKON (SENOFILCON A) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER | Vistakon, Division of Johnson & Johnson Vision Car | Dec 20, 2005 | APPR |
| P000030 | FOCUS NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES | Alcon Laboratories, Inc. | Oct 12, 2001 | APPR |
| P010019 | FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES | Alcon Laboratories, Inc. | Oct 11, 2001 | APPR |
| P990085 | VISTAKON (LENEFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND VISIBILITY TINTED WITH UV BLOCKER | Johnson & Johnson Vision Care, Inc. | Feb 16, 2001 | APWD |
| P990072 | W-55 (METHAFILCON A) AND HORIZON 55 SOFT EXTENDED WEAR CONTACT LENSES | Westcon Contact Lens Co., Inc. | Aug 22, 2000 | APWD |
| P980006 | PURE VISION VISIBILITY TINTED CONTACT LENS FOR EXTENDED WEAR | Bausch & Lomb, Inc. | Feb 5, 1999 | APPR |
| P960039 | SOFT-55 EW APHAKIC, VIFILCON A(SOFT CONTACTS FOR EXTENDED WEAR) | Unilens Corporation, USA | Apr 17, 1997 | APWD |
| P960022 | SOFLENS66(TM) | Bausch & Lomb, Inc. | Dec 16, 1996 | APPR |
| P940013 | PRECISION(TM) UV (VASURFILCON) | Alcon Laboratories, Inc. | Sep 30, 1994 | APWD |
| P890049 | FINISHED METHAFILCON A CONTACT LENSES | Lombart Lenses, Ltd. | Sep 28, 1989 | APWD |
| P890040 | SOF-FORM 55 (METHAFILCON A) SOFT (HYDROPHILIC LENS | Unilens Corp., USA | Sep 28, 1989 | APPR |
| P890023 | H55 HYDROPHILIC CONTACT LENS | The Cooper Companies | Sep 19, 1989 | APPR |
| P880029 | B AND L 70 LIDOFILCON A CONTACT LENSE | Bausch & Lomb, Inc. | Apr 29, 1988 | APWD |
| P860040 | SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES | Wavetouch Technologies, LLC | Feb 19, 1987 | APPR |
| P850079 | HYDRASOFT (METHAFILCON B) CONTACT LENS | CooperVision, Inc. | Jan 31, 1986 | APPR |
| P850078 | KONTUR 55 EW | Kontur Kontact Lens Co., Inc. | Jan 31, 1986 | APWD |
| P850077 | 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
