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)

ADL 400 ND;YAG LASER SYSTEM FOR INTRORAL SOFT TIS.

K-Number: K920106 · 1992-03-13

ApplicantSunrise Technologies, Inc.
Decision Date1992-03-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ADL 400 ND;YAG LASER SYSTEM FOR INTRORAL SOFT TIS. is the device name listed in this FDA 510(k) record. The listed applicant is Sunrise Technologies, Inc.. It received FDA 510(k) clearance on 1992-03-13 under 510(k) number K920106. 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 ADL 400 ND;YAG LASER SYSTEM FOR INTRORAL SOFT TIS.?

ADL 400 ND;YAG LASER SYSTEM FOR INTRORAL SOFT TIS. is a medical device that received FDA 510(k) clearance on 1992-03-13. The listed applicant is Sunrise Technologies, Inc.. The 510(k) number is K920106.

When did ADL 400 ND;YAG LASER SYSTEM FOR INTRORAL SOFT TIS. receive FDA 510(k) clearance?

ADL 400 ND;YAG LASER SYSTEM FOR INTRORAL SOFT TIS. received FDA 510(k) clearance on 1992-03-13, under 510(k) number K920106.

Who is the listed applicant for ADL 400 ND;YAG LASER SYSTEM FOR INTRORAL SOFT TIS.?

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

What is the FDA product code for ADL 400 ND;YAG LASER SYSTEM FOR INTRORAL SOFT TIS.?

The FDA product code for ADL 400 ND;YAG LASER SYSTEM FOR INTRORAL SOFT TIS. is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sunrise Technologies, 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.

K962192SUNRISE CURING LAMPK942542SLASE 210 PLUS HOLMIUM LASER SYSTEMK932997MICROPREP CAVITY PREPERATION SYSTEMK933007SLASE 210 & SLASE 210 PLUS HOLMIUM LASER SYSTEMSK933017MODEL 5030 SUCTION HANDPIECE SYSTEMK931774UPGRADED PACKAGE FOR DLASE 300 PULSED DENTAL LASER

View all 18 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.

↑