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Digital Prismatic Correction

Page Type
Product Code
Definition
The device is intended to provide digital image adjustments in a display system in accordance with a user’s prism prescription. The device can be used in conjunction with optical lenses for refractive correction.
Physical State
it is a software that utilizes a user’s prism prescription as an input and provides digital image adjustments as output perceived on a display system.
Technical Method
The device converts a user’s prism prescription into adjustment parameters that are utilized by a display system to provide digital image adjustments in horizontal and/or vertical dimensions.
Target Area
Eye
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
886.1655
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible
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CFR § 886.1655 Ophthalmic Fresnel prism

§ 886.1655 Ophthalmic Fresnel prism.

(a) Identification. An ophthalmic Fresnel prism is a device that is a thin plastic sheet with embossed rulings which provides the optical effect of a prism. The device is intended to be applied to spectacle lenses to give a prismatic effect.

(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. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 66 FR 38812, July 25, 2001]

FDA Browser

by Innolitics

OP/
subpart-b—diagnostic-devices/
SCW
View Source

Digital Prismatic Correction

Page Type
Product Code
Definition
The device is intended to provide digital image adjustments in a display system in accordance with a user’s prism prescription. The device can be used in conjunction with optical lenses for refractive correction.
Physical State
it is a software that utilizes a user’s prism prescription as an input and provides digital image adjustments as output perceived on a display system.
Technical Method
The device converts a user’s prism prescription into adjustment parameters that are utilized by a display system to provide digital image adjustments in horizontal and/or vertical dimensions.
Target Area
Eye
Regulation Medical Specialty
Ophthalmic
Review Panel
Ophthalmic
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
886.1655
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible
View Source

CFR § 886.1655 Ophthalmic Fresnel prism

§ 886.1655 Ophthalmic Fresnel prism.

(a) Identification. An ophthalmic Fresnel prism is a device that is a thin plastic sheet with embossed rulings which provides the optical effect of a prism. The device is intended to be applied to spectacle lenses to give a prismatic effect.

(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. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 66 FR 38812, July 25, 2001]