Last synced on 25 November 2022 at 11:04 pm

Prosthesis, Eyelid Spacer/Graft, Biologic

Page Type
Product Code
Definition
For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid.
Physical State
Lyophilized sheets of SIS cut to various sizes
Technical Method
Natural collagen matrix which reinforces tissue and promotes cellular ingrowth
Target Area
Eyelid, eyelid area
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
886.3130
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.3130 Ophthalmic conformer

§ 886.3130 Ophthalmic conformer.

(a) Identification. An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery. ]

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

[52 FR 33355, Sept. 2, 1987, as amended at 63 FR 59230, Nov. 3, 1998]

Prosthesis, Eyelid Spacer/Graft, Biologic

Page Type
Product Code
Definition
For implantation to reinforce and aid in reconstruction of the soft tissues of the eyelid.
Physical State
Lyophilized sheets of SIS cut to various sizes
Technical Method
Natural collagen matrix which reinforces tissue and promotes cellular ingrowth
Target Area
Eyelid, eyelid area
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K) Exempt
Device Classification
Class 2
Regulation Number
886.3130
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.3130 Ophthalmic conformer

§ 886.3130 Ophthalmic conformer.

(a) Identification. An ophthalmic conformer is a device usually made of molded plastic intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following surgery. ]

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

[52 FR 33355, Sept. 2, 1987, as amended at 63 FR 59230, Nov. 3, 1998]