FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IRIS Pi Q switched Nd YAG laser
K Number: K221789
·
Decision Aug 9, 2022
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
10
Review Days
49
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Basic Information
- Device Name
- IRIS Pi Q switched Nd YAG laser
- K Number
- K221789
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Med USA, Inc.
- Date Received
- June 21, 2022
- Decision Date
- August 9, 2022
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
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