Atlas FDA

OPTI-ZYME(R)

FDA 510(k) clearance K873548 · decided 1987-09-29

Clearance details

K-number
K873548
Device name
OPTI-ZYME(R)
Applicant
Alcon Laboratories
Decision
Substantially Equivalent
Date received
1987-08-31
Decision date
1987-09-29
Days to decision
29 days
Clearance type
Traditional
Product code
LPN
Device class
2
Regulation number
886.5928
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Fort Worth, TX, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Alcon Laboratories

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Bausch + Lomb Preservative Free Lubricating and Rewetting Drops (K222541)Bausch & Lomb, Incorporated2022-12-06
Aqua Naina Plus Sterile Saline Solution (K221263)Chemtex USA, Inc.2022-10-12
ABT12 multi-purpose solution (K202932)Bausch & Lomb, Incorporated2021-05-28
OTE MPS 045 Multi-purpose Lens Care Solution (K210051)Ote North America, LLC2021-05-26
Aqua Naina Sterile Saline Solution (K193441)Chemtex USA, Inc.2020-05-26
PuriLens Plus Preservative Free Saline (K200747)The Lifestyle Company, Inc.2020-05-15
Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution (K191872)Menicon Co, Ltd.2020-03-02
REFRESH RELIEVA For CONTACTS (K190674)Allergan, Inc.2019-08-08
AOCup Lens Case with AODisc (K191795)Alcon Laboratories, Inc.2019-07-31
Bausch + Lomb Sensitive Eyes Plus Saline Solution (K170483)Bausch & Lomb, Incorporated2017-04-11
NNR06 Multi-Purpose Solution (K161819)Bausch & Lomb, Incorporated2016-11-25
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc (K162597)Alcon Laboratories, Inc.2016-10-19

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
VISCOAT™ Ophthalmic Viscosurgical Device; DUOVISC™ Ophthalmic Viscoelastic System; DISCOVISC™ Ophthalmic Viscosurgical D (P840064/S091)Alcon Laboratories2025-10-03
VISCOAT™ Ophthalmic Viscosurgical Device, DISCOVISC™ Ophthalmic Viscosurgical Device (P840064/S090)Alcon Laboratories2025-07-25
DISCOVISC Ophthalmic Viscosurgical Device (P840064/S088)Alcon Laboratories2025-02-26
VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC Ophthalmic Viscosurgical System (consists of PROVISC and VISCOAT), DIS (P840064/S086)Alcon Laboratories2024-08-12
PMMA Single-Piece Anterior Chamber IOL (P880087/S033)Alcon Laboratories2024-06-20
PMMA Multiple and Single-Piece Posterior Chamber IOLs (P840060/S051)Alcon Laboratories2024-06-20
PMMA Multiple and Single-Piece Posterior Chamber IOLs (P810032/S071)Alcon Laboratories2024-06-20
VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System, DISCOVISC™ Ophthalmic Viscosurgical (P840064/S085)Alcon Laboratories2024-06-17