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Device
lens, intraocular, phakic
Review Panel
Ophthalmic
Product Code
MTA
Premarket Review
Ophthalmic Devices
(DHT1A)
Ophthalmic Devices (DHT1A)
Submission Type
PMA
Device Class
3
Total Product Life Cycle (TPLC)
TPLC Product Code Report
GMP Exempt?
No
Summary Malfunction
Reporting
Ineligible
Implanted Device?
Yes
Life-Sustain/Support Device?
No
Recognized Consensus Standards
10-57 ANSI Z80.13-2007 (R2022)
American National Standard for Ophthalmics - Phakic Intraocular Lenses
10-95 ISO 11979-6 Third edition 2014-10-01
Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing
10-98 ISO 11979-2 Second edition 2014-08-15
Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods
10-119 ISO 11979-5 Third edition 2020-09
Ophthalmic implants - Intraocular Lenses - Part 5: Biocompatibility
10-124 ISO 11979-1 Fourth edition 2018-11
Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary
10-133 ISO 11979-10 Second edition 2018-03
Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes.
Third Party Review
Not Third Party Eligible
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