FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Cellene CO2 Laser System
K Number: K182270
·
Decision Nov 2, 2018
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
10
Review Days
72
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Cellene CO2 Laser System
- K Number
- K182270
- 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
- August 22, 2018
- Decision Date
- November 2, 2018
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEX), ordered by most recent decision date.
Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PICOSURE WORKSTATION
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LumiGlam Laser System (SHE-LSP601-3)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LASEmaR 1500
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LUNE PureHygiene
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Boston 2910 (Boston 2910)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Bio-Med USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K221789 | IRIS Pi Q switched Nd YAG laser | Aug 9, 2022 | Substantially Equivalent |
| K212082 | Picore | Oct 6, 2021 | Substantially Equivalent |
| K163638 | Dental 5 Multi Diode laser | May 15, 2017 | Substantially Equivalent |
| K140837 | LUCID LY | Sep 24, 2014 | Substantially Equivalent |
| K133774 | ATOVEN | Jun 6, 2014 | Substantially Equivalent |
| K123710 | UNITOX BOTOX SYRINGE | May 9, 2013 | Substantially Equivalent |
| K121268 | WANDY DISPERSVIE ELECTRODE | Dec 20, 2012 | Substantially Equivalent |
| K111831 | MX-7000 MICROXEL | Dec 19, 2011 | Substantially Equivalent |
| K081547 | BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC | Sep 8, 2008 | Substantially Equivalent |