Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-28 @ 11:49 PM
Study NCT ID:
NCT04881058
Status:
COMPLETED
Last Update Posted:
2023-06-27
First Post:
2021-05-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post Market Clinical Follow Up Study to Collect Additional Data and Imaging
Sponsor:
Cynosure, Inc.
Organization:
Study Overview
Official Title:
Post Market Clinical Follow Up Study to Collect Additional Data and Imaging
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The intended use of the PicoSure device with focus lens array used in this study is to assess images to support additional marketing claims for the treatment of pigmentation and mild to moderate wrinkles.
Detailed Description:
Up to 10 subjects will be enrolled at 1 study center. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 4 treatments on the face with the PicoSure device.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: