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Light Based Imaging

Page Type
Product Code
Definition
Emission and collection of light to create an image for medical purposes
Physical State
Device is a light source in a housing and light detectors in a housing that can be aimed at a target tissue
Technical Method
Device emits light that is collected from the target tissue and then analyzed to provide information about the target
Target Area
Intact human skin
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4580
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 878.4580 Surgical lamp

§ 878.4580 Surgical lamp.

(a) Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

(b) Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

[53 FR 23872, June 24, 1988, as amended at 84 FR 71814, Dec. 30, 2019]

Light Based Imaging

Page Type
Product Code
Definition
Emission and collection of light to create an image for medical purposes
Physical State
Device is a light source in a housing and light detectors in a housing that can be aimed at a target tissue
Technical Method
Device emits light that is collected from the target tissue and then analyzed to provide information about the target
Target Area
Intact human skin
Regulation Medical Specialty
General and Plastic Surgery
Review Panel
General and Plastic Surgery
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
878.4580
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 878.4580 Surgical lamp

§ 878.4580 Surgical lamp.

(a) Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

(b) Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

[53 FR 23872, June 24, 1988, as amended at 84 FR 71814, Dec. 30, 2019]