Accure Acne, Inc.
United StatesFDA applicant, unverified FDA FEI 3017786046
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 11 ongoing
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Accure Acne, Inc. makes
Accure Acne, Inc. manufactures laser-based systems designed for acne treatment, including the Accure Laser and Accure Laser System. These devices are intended for controlled skin resurfacing and targeted acne lesion reduction through precise laser energy delivery.
The company’s portfolio is classified under FDA’s Class II medical devices and is authorised through the 510(k) clearance process. These devices are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.
Catalogue
Accure Laser Ref K222109
Regimes: 510(k) Registry: 510(k)Accure Laser System Ref K242035
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3017786046
- Address
- 4699 Nautilus Court S, Boulder, CO, 80301
FDA recalls
FDA recall records list 1 recall initiated by Accure Acne, Inc., initiated on 2023-12-06. By recorded status: 1 ongoing. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 1
- 2024 0
- 2025 0
- 2026 0
2023
- 6 Dec 2023 Z-0778-2024 Class II Ongoing Laser system's spot tracking system may become misaligned resulting in the possible risk of delivery of higher-than-expected laser energy to epidermal tissue, which may cause blistering.
Frequently asked questions
How many devices does Accure Acne, Inc. have in the registry?
The registry currently lists 2 devices for Accure Acne, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Accure Acne, Inc.'s devices?
Among its 2 most recently registered devices, Accure Acne, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Accure Acne, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Accure Acne, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Accure Acne, Inc.?
FDA recall records list 1 recall initiated by Accure Acne, Inc., the most recent initiated on 6 Dec 2023. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Accure Acne, Inc. in the registry?
The most recently registered devices listed for Accure Acne, Inc. include Accure Laser and Accure Laser System.