Facility

ACCURE ACNE, INC.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3017786046
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	4699 Nautilus Court S Boulder, CO, US 80301
Registration status	Active · expires 2026
Parent company	Accure Acne, Inc. (owner-operator 10086609)
Brand names	Accure Laser System

Activity by year

Recalls (1)

Devices registered here (1)

Powered Laser Surgical Instrument
Product code GEX (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4810

Recalls & enforcement

Class IIOngoing2023-12-06
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.

All facilities operated by Accure Acne, Inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ACCURE ACNE, INC. (FEI 3017786046) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3017786046-accure-acne-inc/

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