PicoLO Nd:YAG Picosecond Laser System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K183392 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The PicoLO Nd:YAG Picosecond Laser System is a picosecond laser device designed for medical aesthetic applications, including pigmentation lesion treatment, tattoo removal, scar correction, and skin rejuvenation. It operates at wavelengths of 1064 nm and 532 nm, delivering precise picosecond pulses for tissue interaction.
This system is intended for use in clinical settings by trained professionals, providing adjustable energy delivery via specialized handpieces. Supplied as a reusable medical device, it is regulated under FDA 510(k) clearance (K183392) and falls under the General, Plastic Surgery advisory committee category. No sterility or single-use specifications are noted in the regulatory data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: The True Picosecond Laser | PICOLO LASER, PicoLO Premium — LASEROPTEK, LASEROPTEK
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K183392 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Laseroptek Co., Ltd
- FDA Applicant
- Laseroptek Co., Ltd.
Sources (1)
- FDA 510(k) K183392 24 fields · synced Sep 19, 2026