Accent XL
FDA 510(k) clearance K160075 · decided 2016-08-17
Clearance details
- K-number
- K160075
- Device name
- Accent XL
- Applicant
- Alma Lasers, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-01-14
- Decision date
- 2016-08-17
- Days to decision
- 216 days
- Clearance type
- Traditional
- Product code
- IMI
- Device class
- 2
- Regulation number
- 890.5300
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Buffalo Grove, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.