Atlas FDA

HPX

74 FDA 510(k) clearances · Product code

51 daysmedian time to decision
181 days90th percentile
74clearances measured

FDA profile

Official device name
Lens, Contact (Polymethylmethacrylate)
Device class
Unclassified
Medical specialty
Unknown
Adverse events (MAUDE)
1995: 2 · 1996: 1 · 1997: 1 · 1998: 3 · 2006: 2 · 2007: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
PMMA CLASIC (K955777)Rand Scientific Corp.1996-05-16
KERATOPLASTY SUTURING LENS (K940106)Visionary Technologies of Miami, Inc.1994-05-25
MULTI-VIEW BIFOCALS (K913081)Camp Contact Lenses1991-10-23
MARTIN-HENSLEY SEGMENT LENS (K897021)Bruce W. Martin O.D. and Edward Hensley1990-06-22
OPTIKEM PMMA CONTACT LENS (K895411)Optikem Polymers, Inc.1990-02-27
ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERY (K874591)Vitreo Dynamics, Co.1988-05-03
CHARTER HARD CONTACT LENS CLEANING SOLUTION (K865111)Paco Pharmaceutical Services, Inc.1987-01-20
BL1 (HARD CONTACT LENS) (K864343)Beta Labs, Inc.1986-11-28
CHARTER LABORATORIES INC. LENS LUBRICANT (K863974)Paco Pharmaceutical Services, Inc.1986-11-10
CHARTER WETTING SOLUTION FOR HARD CONTACT LENSES (K862952)Paco Pharmaceutical Services, Inc.1986-09-25
AQUALUX LENS CASE (K862811)Safeway Products, Inc.1986-09-03
STYLEKEEPER CONTACT LENS CARRYING CASE (K861643)Allergan, Inc.1986-06-02
EASY EYES TM LENS CARRYING CASE (K860677)Applied Laboratories, Inc.1986-05-29
WETTING & SOAKING HARD CONTACT LENS SOLUTION (K861712)Maurry Biological Co.1986-05-29
LENSKEEPER CONTACT LENS CARRYING CASE (K861642)Allergan, Inc.1986-05-29
BAUSCH & LOMB LENS CARRYING CASE (K854968)Bausch & Lomb, Inc.1986-04-04
DAILY HARD CONTACT LENS CLEANER (K853809)Maurry Biological Co.1986-03-11
HARD CONTACT LENS CLEANING & SOAKING SOLUTION (K853808)Maurry Biological Co.1986-03-11
UVASORB-400 (K854442)Optatint, Inc.1986-02-19
ALL-IN-ONE HARD CONTACT LENS SOLUTION (K853807)Maurry Biological Co.1985-12-16
HARD CONTACT LENS SOAKING SOLUTION (K853811)Maurry Biological Co.1985-12-16
WETTING SOLUTION FOR HARD CONTACT LENSES (K853810)Maurry Biological Co.1985-12-16
KESTREL CONTACT LENS STORAGE CASE(POLYSTYRENE) (K853729)Ryder Intl. Corp.1985-12-13
KESTREL CONTACT LENS STORAGE CASE(NORYL) (K853728)Ryder Intl. Corp.1985-12-13
EASY EYES TM LENS CARRYING CASE (K853870)Applied Laboratories, Inc.1985-12-10
IN A WINK LUBRICATING & REWETTING DROPS (K853445)Ciba Vision Care1985-11-29
RHODA-LUX LENS BLANKS (K850909)Optatint, Inc.1985-10-04
SIGHT SAVER ALL PURPOSE LENS CARRYING CASE (K852384)Bausch & Lomb, Inc.1985-07-31
ON TARGET (K851887)Newman Assoc.1985-05-30
MARLIN CONTACT LENS CASE (K851497)Marlin Industries1985-05-16
PROFESSIONAL SUPPLIES, INC.LENS CARRYING CASE (K850046)Professional Supplies, Inc.1985-04-15
EASY EYES TM LENS CARRYING CASE (K841881)Eaton Medical Corp.1984-12-03
LENSKEEPER LENS CARRYING CASE (K843342)Allergan Pharmaceuticals, Inc.1984-11-19
BENZETHONIUM CHLORIDE (K833903)Blairex Laboratories, Inc.1984-05-30
HARD CONTACT LENS CASE (K831973)Moonbeam International, Inc.1983-10-19
SENSITIVE EYES (K832706)Bausch & Lomb, Inc.1983-10-04
HARD CONTACT LENS CLEANER (K832810)Blairex Laboratories, Inc.1983-09-29
CLERZ LUBRICATING & REWETTING EYE DROPS (K830740)CooperVision, Inc.1983-06-02
GLISLENS (K823528)Bio-Products, Inc.1982-12-22
GFB-B CONTACT LENS BLANKS (K822315)Hamel, Park, Mccabe & Saunders1982-11-16
PRE-SERT (K822706)Allergan, Inc.1982-10-22
CLEAN-N-SOAK (K822707)Allergan, Inc.1982-10-18
LE CASE HARD CONTACT LENS STORAGE CASE (K822495)Optikem International, Inc.1982-09-30
OXY-PMMA (K821866)Petrarch Systems & Professional Pharm1982-09-14
LENS EASY ON (K822105)L.E.O. Corp.1982-08-20
TOTAL (K821054)Allergan, Inc.1982-05-13
SOAKARE (K821052)Allergan, Inc.1982-05-13
LIQUIFILM WETTING SOLUTION (K821051)Allergan, Inc.1982-05-13
BLINK-N-CLEAN (K821055)Allergan, Inc.1982-05-10
OPTACRY/95 GRAY CONTACT LENS BLANKS (K820817)Optacryl, Inc.1982-05-05
OPTACRY/95 BLUE CONTACT LENS BLANKS (K820815)Optacryl, Inc.1982-05-05
OPTACRY/ 95 GREEN CONTACT LENS BLANKS (K820816)Optacryl, Inc.1982-05-05
STERICIDAL (K820325)Breger Mueller West1982-04-21
CONCENTRATED CLEANER FOR HARD CONTACTS (K820818)Bausch & Lomb, Inc.1982-04-09
BAUSCH & LOMB STERILE ALL PURPOSE SOLU (K820511)Bausch & Lomb, Inc.1982-04-09
LENS-PAC (K813528)The Plactory1982-01-12
CONTACT LENS MATERL (K811010)Paragon Optical Co.1981-12-09
LENSINE EXTRA STRENGTH CLEANER (K812433)CooperVision, Inc.1981-09-21
CONTACT LENS CLEANER (K812172)Alcon Laboratories1981-08-31
BARNES-HIND WEEKLY CLEANER (K812135)Barnes-Hind, Inc.1981-08-31
OPTOCRYL CONTACT LENS BLANKS (K810130)Optacryl, Inc.1981-06-11
KERATOPLASTY SUTURING LENS (K802593)Paris Contact Lens Laboratory1980-12-22
BARNES-HOND HARD CONTACT LENS STOR. CASE (K800582)Barnes-Hind, Inc.1980-03-25
DURALITE LENS (K800192)American Optical Corp.1980-03-12
VISALENS ALL PURPOSE SOLUTION FOR LENS (K791523)Pfizer, Inc.1980-02-19
CONTACT LENSES MADE OF POLYMETHYLMETHACR (K792224)Contact Lenses of the Pacific, Inc.1979-12-11
VISALENS CONCENTRATED CLEANER CONT LENS (K791524)Pfizer, Inc.1979-11-20
CONTACT LENS CLEANSER (K780823)Ketchum Laboratories, Inc.1978-06-30
AUTO-CON (K781007)Barnes-Hind, Inc.1978-06-30
LENS, CONTACT, HARD (K770582)Berea Contact Lens, Inc.1977-05-06
CASE, CONTACT LENS, PLASTIC (K760046)Tomlin B. Horsley, Jr.1976-10-21
LENSES, CONTACT, POLYMETHYL METHACRYLATE (K760213)Progressive Affiliated Labs, Inc.1976-08-09
BUTTONS, PMMA (FOR CONTACT LENSES) (K760204)Burton Parsons & Co., Inc.1976-08-04
LENS, HARD CONTACT (K760126)Tru-Form Optics, Inc.1976-07-20

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Every clearance here is in the API, with alerts when new ones post.