ONE · Powered Light Based Non-Laser Surgical Instrument
General, Plastic Surgery · 21 CFR 878.4810 · Class 2
Overview
| Product Code | ONE |
|---|---|
| Device Name | Powered Light Based Non-Laser Surgical Instrument |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 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 | handLITE (TN19S) | iSMART Developments, Ltd. | Apr 18, 2025 | SESE |
| K171055 | Philips BlueControl | Philips Electronics Nederland B.V. | Jul 6, 2017 | SESE |
| K103415 | TANDA MAX | Pharos Life Corporation | Jan 3, 2011 | SESE |
| K100628 | PLASMALUXLS | Daavlin Distributing Co. | Nov 24, 2010 | SESE |
| K091467 | BABY QUASAR | Silver Bay, LLC | Sep 17, 2010 | SESE |
| K091125 | CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2 | Verilux | Sep 3, 2010 | SESE |
| K092800 | 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
