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)

EPIC 10S

K-Number: K130465 · 2013-04-11

ApplicantBiolase Technology, Inc.
Decision Date2013-04-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EPIC 10S is the device name listed in this FDA 510(k) record. The listed applicant is Biolase Technology, Inc.. It received FDA 510(k) clearance on 2013-04-11 under 510(k) number K130465. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPIC 10S?

EPIC 10S is a medical device that received FDA 510(k) clearance on 2013-04-11. The listed applicant is Biolase Technology, Inc.. The 510(k) number is K130465.

When did EPIC 10S receive FDA 510(k) clearance?

EPIC 10S received FDA 510(k) clearance on 2013-04-11, under 510(k) number K130465.

Who is the listed applicant for EPIC 10S?

The FDA 510(k) record lists Biolase Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPIC 10S?

The FDA product code for EPIC 10S is GEX. This falls under the Gastroenterology category.

Other records listing Biolase Technology, Inc. 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.

K122368WATERLASE IPLUS ALL TISSUE LASERK121327DIOLASE 10SK121286EPIC 10K101658WATERLASE MD TURBO PLUS MODEL 7200XXXK093852EZLASE 3 LASER SYSTEMK091746WATERLASE MD, MODEL 7100102

View all 31 devices →

Related Devices (Code: GEX)

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.

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T 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.

↑