Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4810](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4810) → ONE — Powered Light Based Non-Laser Surgical Instrument

# ONE · Powered Light Based Non-Laser Surgical Instrument

_General, Plastic Surgery · 21 CFR 878.4810 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONE

## Overview

- **Product Code:** ONE
- **Device Name:** Powered Light Based Non-Laser Surgical Instrument
- **Regulation:** [21 CFR 878.4810](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4810)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **3rd-party reviewable:** yes

## Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

## Classification Rationale

(1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

## Recent Cleared Devices (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K250224](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONE/K250224.md) | handLITE (TN19S) | iSMART Developments, Ltd. | Apr 18, 2025 | SESE |
| [K171055](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONE/K171055.md) | Philips BlueControl | Philips Electronics Nederland B.V. | Jul 6, 2017 | SESE |
| [K103415](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONE/K103415.md) | TANDA MAX | Pharos Life Corporation | Jan 3, 2011 | SESE |
| [K100628](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONE/K100628.md) | PLASMALUXLS | Daavlin Distributing Co. | Nov 24, 2010 | SESE |
| [K091467](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONE/K091467.md) | BABY QUASAR | Silver Bay, LLC | Sep 17, 2010 | SESE |
| [K091125](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONE/K091125.md) | CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2 | Verilux | Sep 3, 2010 | SESE |
| [K092800](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONE/K092800.md) | ANTI-WRINKLE (AGING) LIGHT, MODEL AAL | Led Intellectual Properties, LLC | Feb 4, 2010 | SESE |

## Top Applicants

- Daavlin Distributing Co. — 1 clearance
- Led Intellectual Properties, LLC — 1 clearance
- Pharos Life Corporation — 1 clearance
- Philips Electronics Nederland B.V. — 1 clearance
- Silver Bay, LLC — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONE](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/ONE)

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