Chrysalis Intelligence · Product Codes · ONG

ONG · Powered Laser Surgical Instrument With MicrobeamFractional Output

General, Plastic Surgery · 11 clearances · 6 unique sponsors

Device class
Class II
Regulation 878.4810
Total clearances
11
2020-04-30 → 2025-10-20
Last 12 months
1
Unique sponsors
6
Definition

What is Powered Laser Surgical Instrument With MicrobeamFractional Output

A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. The laser output is in form of tiny beams in micro range. Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic to destroy, remove or coagulate tissue, generally soft tissue. Indication for Use can be general and/or specific. The classification regulation 21 CFR 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.
Medical specialty
General, Plastic Surgery
Review panel
SU
Regulation number
878.4810
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
AVAVA, Inc. 5 1 2025-10-20
Shanghai Apolo Medical Technology Co., Ltd. 2 0 2025-07-02
Paradigm Medical Corporation 1 0 2022-06-03
Wingderm Electro-Optics , Ltd. 1 0 2020-04-30
Lutronic Corporation 1 0 2025-07-31
Lutronic Aesthetic 1 0 2024-01-02
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
17999 CPT Medium Unlisted procedure, skin, mucous membrane and subcutaneous tissue for fractional laser ablation
96999 CPT Medium Unlisted special dermatologic procedure for aesthetic laser treatment
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-10-20 K252155 AVAVA, Inc. AVAVA™ Skin Treatment System
2025-07-31 K244060 Lutronic Corporation eCO2 3D
2025-07-02 K251031 Shanghai Apolo Medical Technology Co., Ltd. Fiber Laser Treatment Systems (HS-232,HS-233)
2025-04-14 K250402 AVAVA, Inc. AVAVA™ Skin Treatment System
2024-01-02 K233550 Lutronic Aesthetic MOSAIC 3D (Surgical Laser)
2023-06-22 K223871 AVAVA, Inc. Miria Skin Treatment System
2022-11-21 K221268 AVAVA, Inc. SR-1 Skin Treatment System
2022-10-13 K221770 Shanghai Apolo Medical Technology Co., Ltd. Fiber Laser Treatment System
2022-06-03 K213332 Paradigm Medical Corporation Multifrax Laser System
2021-04-13 K202884 AVAVA, Inc. SR-1 Skin Treatment System
2020-04-30 K192350 Wingderm Electro-Optics , Ltd. Medical Non-Ablative Fractional Laser Systems