Atlas FDA

HORIZON(TM) YAG LASER MODEL 2000

FDA premarket approval P850001/S002 · decided 1985-09-18

Approval details

PMA number
P850001
Supplement
S002
Trade name
HORIZON(TM) YAG LASER MODEL 2000
Generic name
Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
Applicant
CooperVision, Inc.
Date received
1985-03-25
Decision date
1985-09-18
Days to decision
177 days
Decision code
APPR
Product code
LOI
Advisory committee
Ophthalmic
Expedited review
No
Location
San German, PR

Class III intelligence, same tools

PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.

510(k) clearances by this applicant

RecordFirmDate
Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker (K234127)CooperVision, Inc.2024-01-25
MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens (K220070)CooperVision, Inc.2022-02-04
Avaira Vitality (K213164)CooperVision, Inc.2021-10-26
Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A) (K202756)CooperVision, Inc.2020-10-20
MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC (K191763)CooperVision, Inc.2020-03-23
MyDay (K190965)CooperVision, Inc.2019-04-29
Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker (K181920)CooperVision, Inc.2018-12-11
Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens (K160803)CooperVision, Inc.2016-07-13