Cleared Traditional

K262628 - Picosecond Laser treatment system (Z180)

K262628 is an FDA 510(k) clearance for Picosecond Laser treatment system (Z180), manufactured by Sanhe PERFECTLASER Technology Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code GEX cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K262628 · Sanhe PERFECTLASER Technology Co., Ltd. · General & Plastic Surgery device

Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)

Optimized for regulatory review, auditing and printing

Oct 2026

Decision

83d

Days

Class 2

Risk

K262628 is an FDA 510(k) clearance for the Picosecond Laser treatment system (Z180). Classified as Powered Laser Surgical Instrument within the GEX classification (a category for powered laser surgical instruments across multiple specialties), Class II - Special Controls.

Submitted by Sanhe PERFECTLASER Technology Co., Ltd. (Langfang, CN). The FDA issued a Cleared decision on October 20, 2026 after a review of 83 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K262628

510(k) Number	K262628 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 29, 2026
Decision Date	October 20, 2026
Days to Decision	83 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

32d faster than avg

Panel avg: 115d · This submission: 83d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

GEX Device Classification - Class 2, Special Controls

Product Code	GEX Powered Laser Surgical Instrument
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 878.4810
Definition	A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. Typically Indicated To To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue, For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ent), Gynecology, Neurosurgery, Orthopedics (soft Tissue), Dental And Oral Surgery, And Dentistry. 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.

What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Beijing Believe-Med Technology Service Co., Ltd.

Ray Wang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GEX Powered Laser Surgical Instrument

All 2892

Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K262628.

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FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K262628

Sanhe PERFECTLASER Technology Co., Ltd.

Langfang · CN

Yongchao Lian

Regulatory Consultant

Beijing Believe-Med Technology Service Co., Ltd.

Ray Wang

FDA regulatory affairs consulting firms →

Regulatory profile

2 submissions 2 cleared

100% clearance rate · Active in General & Plastic Surgery

View all devices by Sanhe PERFECTLASER Technology Co., Ltd. →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: October 20, 2026. Record added to 510k Database: November 2026. Enriched with classification and manufacturer data: November 2026.

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