New Era
FDA 510(k) clearance K182604 · decided 2018-11-14
Clearance details
- K-number
- K182604
- Device name
- New Era
- Applicant
- Step UP Skin Laser, LLC
- Decision
- Substantially Equivalent
- Date received
- 2018-09-21
- Decision date
- 2018-11-14
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.