Solta Medical Inc
⚠️ Moderate Risk
FEI: 3003079710 • Pleasanton, CA • UNITED STATES
FEI Number
3003079710
Location
Pleasanton, CA
Country
UNITED STATESAddress
7031 Koll Center Pkwy Ste 206, , Pleasanton, CA, United States
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
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.
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 |
|---|---|---|---|
| 8/31/2018 | 79OUPPOWERED SURGICAL INSTRUMENTS FOR IMPROVEMENT IN THE APPEARANCE OF CELLULITE | Division of Southwest Imports (DSWI) | |
| 8/12/2016 | 79KDDKIT, SURGICAL INSTRUMENT, DISPOSABLE | Cincinnati District Office (CIN-DO) | |
| 11/6/2015 | 79LFLINSTRUMENT, ULTRASONIC SURGICAL | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 8/18/2015 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 2/25/2015 | 79ONGPOWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM\FRACTIONAL OUTPUT | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Solta Medical Inc's FDA import refusal history?
Solta Medical Inc (FEI: 3003079710) has 5 FDA import refusal record(s) in our database, spanning from 2/25/2015 to 8/31/2018.
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. Solta Medical Inc's FEI number is 3003079710.
What types of violations has Solta Medical Inc received?
Solta Medical Inc has been cited for 4 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 Solta Medical Inc come from?
All FDA import refusal data for Solta Medical Inc 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.