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Product Classification

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Device

lens, intraocular, accommodative

Regulation Medical Specialty

Ophthalmic

Review Panel

Ophthalmic

Product Code

NAA

Premarket Review

Ophthalmic Devices (DHT1A)
Ophthalmic Devices (DHT1A)

Submission Type

PMA

Regulation Number

886.3600

Device Class

3

Total Product Life Cycle (TPLC)

TPLC Product Code Report

GMP Exempt?

No

Summary Malfunction
Reporting

Eligible

Implanted Device?

Yes

Life-Sustain/Support Device?

No

Recognized Consensus Standards

10-78 ISO 11979-3 Third edition 2012-12-01
Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods
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
10-105 ISO 11979-8 Third edition 2017-04
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements
10-115 ANSI Z80.29-2015 (R2020)
American National Standard for Ophthalmics - Accomodative Intraocular Lenses
10-119 ISO 11979-5 Third edition 2020-09
Ophthalmic implants - Intraocular Lenses - Part 5: Biocompatibility
10-120 ISO TR 22979 Second Edition 2017-05
Ophthalmic implants - Intraocular Lenses - Guidance on assessment of the need for clinical investigation of intraocular lens design modifications
10-124 ISO 11979-1 Fourth edition 2018-11
Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary
10-125 ISO 11979-7 Fourth edition 2018-03
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia

Third Party Review

Not Third Party Eligible

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