Cynosure, LLC
⚠️ High Risk
FEI: 1000120578 • Westford, MA • UNITED STATES
FEI Number
1000120578
Location
Westford, MA
Country
UNITED STATESAddress
5 Carlisle Rd, , Westford, MA, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/23/2025 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of Southeast Imports (DSEI) | |
| 3/1/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/2/2022 | 79ONGPOWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM\FRACTIONAL OUTPUT | Division of Northern Border Imports (DNBI) | |
| 8/30/2021 | 79ONGPOWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM\FRACTIONAL OUTPUT | Division of West Coast Imports (DWCI) | |
| 6/20/2018 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Division of Southeast Imports (DSEI) | |
| 9/8/2017 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/8/2017 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/8/2017 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 9/8/2017 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 7/27/2011 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 126FAILS STD | New Orleans District Office (NOL-DO) |
| 9/28/2010 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Florida District Office (FLA-DO) | |
| 9/28/2010 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Florida District Office (FLA-DO) | |
| 9/28/2010 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Florida District Office (FLA-DO) | |
| 9/28/2010 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Florida District Office (FLA-DO) | |
| 9/28/2010 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Florida District Office (FLA-DO) | |
| 9/28/2010 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Florida District Office (FLA-DO) | |
| 9/28/2010 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Florida District Office (FLA-DO) | |
| 9/28/2010 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Florida District Office (FLA-DO) | |
| 9/28/2010 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Florida District Office (FLA-DO) | |
| 9/28/2010 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Florida District Office (FLA-DO) | |
| 9/28/2010 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Florida District Office (FLA-DO) | |
| 9/28/2010 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Florida District Office (FLA-DO) | |
| 9/28/2010 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Florida District Office (FLA-DO) | |
| 2/25/2008 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 47NON STD | New Orleans District Office (NOL-DO) |
| 10/29/2007 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Los Angeles District Office (LOS-DO) | |
| 6/21/2007 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 126FAILS STD | New Orleans District Office (NOL-DO) |
| 12/4/2006 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 126FAILS STD | New Orleans District Office (NOL-DO) |
| 11/18/2005 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 476NO REGISTR | New Orleans District Office (NOL-DO) |
| 11/2/2004 | 79MXGLAMP, UVC (FOR TREATING SKIN AND WOUNDS) | 508NO 510(K) | New York District Office (NYK-DO) |
| 7/16/2003 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Cynosure, LLC's FDA import refusal history?
Cynosure, LLC (FEI: 1000120578) has 30 FDA import refusal record(s) in our database, spanning from 7/16/2003 to 9/23/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Cynosure, LLC's FEI number is 1000120578.
What types of violations has Cynosure, LLC received?
Cynosure, LLC has been cited for 7 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Cynosure, LLC come from?
All FDA import refusal data for Cynosure, LLC is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.