510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Accure Acne, Inc

Boulder, CO, US

ACCURE ACNE, INC. appears in FDA device records in Boulder, CO. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
2
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

FDA records hold 2 510(k) clearances for Accure Acne, Inc between 2022 and 2024. The busiest year on record is 2022, with 1. The most recent is 2024, with 1.

Clearances by year, as a table
510(k) clearance decisions for Accure Acne, Inc, by decision year
YearClearances
20221
20241
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K242035Accure Laser SystemGEXSubstantially Equivalent
K222109Accure LaserGEXSubstantially Equivalent

Registered establishments

FDA registered establishments for Accure Acne, Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30177860463017786046ACCURE ACNE, INC.4699 Nautilus Court S, Boulder, CO 80301 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0778-2024Accure Laser System, Model: PFMS00004Laser 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.Class IIOpen, Classified

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain