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Lens, Prescription, Color Deficiency

Page Type
Product Code
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
886.5844
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.5844 Prescription spectacle lens

§ 886.5844 Prescription spectacle lens.

(a) Identification. A prescription spectacle lens is a glass or plastic device that is a lens intended to be worn by a patient in a spectacle frame to provide refractive corrections in accordance with a prescription for the patient. The device may be modified to protect the eyes from bright sunlight (i.e., prescription sunglasses). Prescription sunglass lenses may be reflective, tinted, polarizing, or photosensitized.

(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; 59 FR 63014, Dec. 7, 1994; 66 FR 38814, July 25, 2001]

Lens, Prescription, Color Deficiency

Page Type
Product Code
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
886.5844
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 886.5844 Prescription spectacle lens

§ 886.5844 Prescription spectacle lens.

(a) Identification. A prescription spectacle lens is a glass or plastic device that is a lens intended to be worn by a patient in a spectacle frame to provide refractive corrections in accordance with a prescription for the patient. The device may be modified to protect the eyes from bright sunlight (i.e., prescription sunglasses). Prescription sunglass lenses may be reflective, tinted, polarizing, or photosensitized.

(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; 59 FR 63014, Dec. 7, 1994; 66 FR 38814, July 25, 2001]