Data / Medical devices / United States / Accure Acne, Inc.
Accure Acne, Inc.: FDA-registered device maker in Boulder, CO, United States, 1 510(k) clearance
Accure Acne, Inc. is registered with the FDA (registration 3017786046) in Boulder, CO, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 11, 2024. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3017786046
- Address
- 4699 Nautilus Court S Suite #205, Boulder, CO, United States, 80301
- Owner or operator
- Accure Acne, Inc. (10086609)
- Roles
- Specification developer
- First device listed
- December 8, 2025
- Registered through
- 2027
- Brand names listed
- Accure Laser System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 11, 2024 | K242035 | Accure Laser System | GEX | Substantially Equivalent | Accure Acne, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 6, 2023 | 93696 | Class II | Ongoing | Accure Laser System, Model: PFMS00004 | 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. | accessdata.fda.gov |
Compare with other makers
Updated October 11, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.