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Corneal Inlay Inserter Handle

Page Type
Product Code
Definition
The corneal inlay inserter handle is a hand-held device intended to be used as an accessory to a corneal inlay inserter. The device extends the length of the inlay inserter to aid in delivering the inlay implant.
Physical State
The inserter handle is hand-held and may be made various materials. The handle does not come into contact with the corneal inlay.
Technical Method
The device extends the length of the inlay inserter to aid in delivering the inlay implant.
Target Area
The corneal inlay handle is used as an accessory to corneal inlay inserter, which delivers a corneal inlay into the eye.
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
886.4355
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.4355 Corneal inlay inserter handle

§ 886.4355 Corneal inlay inserter handle.

(a) Identification. The corneal inlay inserter handle is a hand-held device intended to be used as an accessory to a corneal inlay inserter. The device extends the length of the inlay inserter to aid in delivering the inlay implant.

(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.

[84 FR 14870, Apr. 12, 2019]

Corneal Inlay Inserter Handle

Page Type
Product Code
Definition
The corneal inlay inserter handle is a hand-held device intended to be used as an accessory to a corneal inlay inserter. The device extends the length of the inlay inserter to aid in delivering the inlay implant.
Physical State
The inserter handle is hand-held and may be made various materials. The handle does not come into contact with the corneal inlay.
Technical Method
The device extends the length of the inlay inserter to aid in delivering the inlay implant.
Target Area
The corneal inlay handle is used as an accessory to corneal inlay inserter, which delivers a corneal inlay into the eye.
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
886.4355
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.4355 Corneal inlay inserter handle

§ 886.4355 Corneal inlay inserter handle.

(a) Identification. The corneal inlay inserter handle is a hand-held device intended to be used as an accessory to a corneal inlay inserter. The device extends the length of the inlay inserter to aid in delivering the inlay implant.

(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.

[84 FR 14870, Apr. 12, 2019]