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Inserter/Remover Contact Lens

Page Type
Product Code
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
886.5420
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.5420 Contact lens inserter/remover

§ 886.5420 Contact lens inserter/remover.

(a) Identification. A contact lens inserter/remover is a handheld device intended to insert or remove contact lenses by surface adhesion or suction.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 66 FR 38814, July 25, 2001]

Inserter/Remover Contact Lens

Page Type
Product Code
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
886.5420
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.5420 Contact lens inserter/remover

§ 886.5420 Contact lens inserter/remover.

(a) Identification. A contact lens inserter/remover is a handheld device intended to insert or remove contact lenses by surface adhesion or suction.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 66 FR 38814, July 25, 2001]