Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1410](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1410) → HPB — Clip, Lens, Trial, Ophthalmic

# HPB · Clip, Lens, Trial, Ophthalmic

_Ophthalmic · 21 CFR 886.1410 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPB

## Overview

- **Product Code:** HPB
- **Device Name:** Clip, Lens, Trial, Ophthalmic
- **Regulation:** [21 CFR 886.1410](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1410)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

An ophthalmic trial lens clip is a device intended to hold prisms, spheres, cylinders, or occluders on a trial frame or spectacles for vision testing.

## Classification Rationale

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.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

---

**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPB](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HPB)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
