---
kind: "section"
citation: "21 C.F.R. § 876.1530"
title: "21"
number: "876.1530"
heading: "Endoscopic light-projecting measuring device."
url: "https://uscodex.org/cfr/21/876.1530"
---

# §876.1530. Endoscopic light-projecting measuring device.

- (a) **Identification.** An endoscopic light-projecting measuring device projects light on a mucosal surface and uses software to determine the dimensions of observable features of interest.
- (b) **Classification.** Class II (special controls). The special controls for this device are:
  - (1) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must evaluate:
    - (i) Visualization during the procedure;
    - (ii) Ease of procedure as reported by the intended user; and
    - (iii) **User acceptability of imaging time.**
  - (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
    - (i) Accuracy validation;
    - (ii) Endoscope compatibility testing;
    - (iii) Battery life testing;
    - (iv) Durability testing; and
    - (v) **Light safety testing.**
  - (3) The patient-contacting components of the device must be demonstrated to be biocompatible.
  - (4) Software verification, validation, and hazard analysis must be performed.
  - (5) Electrical, thermal, and mechanical safety testing must be performed.
  - (6) Performance testing must demonstrate electromagnetic compatibility of the device in the intended use environment.
  - (7) Methods and instructions for reprocessing reusable components must be validated.
  - (8) Labeling must include:
    - (i) Device technical parameters, including a description of the accuracy of the device;
    - (ii) Information regarding endoscope compatibility;
    - (iii) Warning for light hazards and protection for patient and operator; and
    - (iv) **Validated reprocessing instructions.**

## Notes

### Amendments

[91 FR 36981, June 22, 2026]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 48 FR 53023, Nov. 23, 1983, unless otherwise noted.

### Amendments

[91 FR 36981, June 22, 2026]