Last synced on 30 September 2022 at 11:05 pm

Brush, Haidinger, (Including Macular Integrity)

Page Type
Product Code
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
886.1090
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.1090 Haidinger brush

§ 886.1090 Haidinger brush.

(a) Identification. A Haidinger brush is an AC-powered device that provides two conical brushlike images with apexes touching which are viewed by the patient through a Nicol prism and intended to evaluate visual function. It may include a component for measuring macular integrity.

(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.

[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, 2001; 72 FR 17400, Apr. 9, 2007]

Brush, Haidinger, (Including Macular Integrity)

Page Type
Product Code
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
886.1090
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.1090 Haidinger brush

§ 886.1090 Haidinger brush.

(a) Identification. A Haidinger brush is an AC-powered device that provides two conical brushlike images with apexes touching which are viewed by the patient through a Nicol prism and intended to evaluate visual function. It may include a component for measuring macular integrity.

(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.

[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, 2001; 72 FR 17400, Apr. 9, 2007]