Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BC-001+ Acne Purifier

K-Number: K170260 · 2017-04-25

ApplicantOriental Inspiration Limited
Decision Date2017-04-25
Product CodeOLP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BC-001+ Acne Purifier is the device name listed in this FDA 510(k) record. The listed applicant is Oriental Inspiration Limited. It received FDA 510(k) clearance on 2017-04-25 under 510(k) number K170260. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BC-001+ Acne Purifier?

BC-001+ Acne Purifier is a medical device that received FDA 510(k) clearance on 2017-04-25. The listed applicant is Oriental Inspiration Limited. The 510(k) number is K170260.

When did BC-001+ Acne Purifier receive FDA 510(k) clearance?

BC-001+ Acne Purifier received FDA 510(k) clearance on 2017-04-25, under 510(k) number K170260.

Who is the listed applicant for BC-001+ Acne Purifier?

The FDA 510(k) record lists Oriental Inspiration Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BC-001+ Acne Purifier?

The FDA product code for BC-001+ Acne Purifier is OLP.

Other records listing Oriental Inspiration Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233046Electrical Neuromuscular Stimulator, Cure TrioK213133Keffort (MC-100, MC-100A)K212285Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)K170269Hee HR Mini

Related Devices (Code: OLP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd.K251843Erchonia EVRLErchonia CorporationK242068LED Light Therapy Mask (RT01)Ningbo Dechang Electrical Machinery Made Co.,LtdK243555LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)Shenzhen Eyco Technology Co., Ltd.K232656BLU TOTALE (Model: ENEOB852)Premier North America, Inc.K230490PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INTDongguan Hunter Electronic Technology Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑