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)

Pulsaderm Acne Device

K-Number: K161941 · 2016-10-19

ApplicantNutra Luxe MD, LLC
Decision Date2016-10-19
Product CodeOLP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Pulsaderm Acne Device is the device name listed in this FDA 510(k) record. The listed applicant is Nutra Luxe MD, LLC. It received FDA 510(k) clearance on 2016-10-19 under 510(k) number K161941. 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 Pulsaderm Acne Device?

Pulsaderm Acne Device is a medical device that received FDA 510(k) clearance on 2016-10-19. The listed applicant is Nutra Luxe MD, LLC. The 510(k) number is K161941.

When did Pulsaderm Acne Device receive FDA 510(k) clearance?

Pulsaderm Acne Device received FDA 510(k) clearance on 2016-10-19, under 510(k) number K161941.

Who is the listed applicant for Pulsaderm Acne Device?

The FDA 510(k) record lists Nutra Luxe MD, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pulsaderm Acne Device?

The FDA product code for Pulsaderm Acne Device is OLP.

Other records listing Nutra Luxe MD, LLC 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.

K162371Pulsaderm ACE-All BlueK160728NutraStim Hair Laser HelmetK150826Nutra Face Lift Model PE8050

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.

↑