Product Code: QCY FDA class 2 21 CFR 878.4810

Laser Absorbing Particles

General, Plastic Surgery

The Laser Absorbing Particles are surgical particles applied to target tissue for the purpose of absorbing laser or light energy during surgical procedures, enabling more controlled and localized energy delivery. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is QCY under regulation 878.4810 in the General and Plastic Surgery specialty. It is not an implant and is not life-sustaining.

510(k)s
2
FEI Numbers
1
Registration Numbers
1
Unique Applicants
2
Years Active
2

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Basic Information

Product Code
QCY
Device Class
FDA class 2
Regulation Number
878.4810
Medical Specialty
General, Plastic Surgery
Review Panel
SU
Submission Type
1

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

Definition

Particles are applied to the target tissue(s) for the purpose of absorbing laser/light energy.

510(k) Clearance History

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Related 510(k) Clearances

This FDA classification is associated with 2 510(k) clearances via K numbers.

K Number Device Name
K192620 SNA-001 Silver Photoparticle Topical Gel
K181518 Sebacia Microparticles

FEI Numbers

This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.