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FDA 510(k)

SL-100 ND:YAG LASER FOR PALLIATION OF GASTRO. MALI

K-Number: K871513 · 1987-07-09

ApplicantMedical Energy, Inc.
Decision Date1987-07-09
Product CodeLNK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SL-100 ND:YAG LASER FOR PALLIATION OF GASTRO. MALI is the device name listed in this FDA 510(k) record. The listed applicant is Medical Energy, Inc.. It received FDA 510(k) clearance on 1987-07-09 under 510(k) number K871513. The device is classified under product code LNK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SL-100 ND:YAG LASER FOR PALLIATION OF GASTRO. MALI?

SL-100 ND:YAG LASER FOR PALLIATION OF GASTRO. MALI is a medical device that received FDA 510(k) clearance on 1987-07-09. The listed applicant is Medical Energy, Inc.. The 510(k) number is K871513.

When did SL-100 ND:YAG LASER FOR PALLIATION OF GASTRO. MALI receive FDA 510(k) clearance?

SL-100 ND:YAG LASER FOR PALLIATION OF GASTRO. MALI received FDA 510(k) clearance on 1987-07-09, under 510(k) number K871513.

Who is the listed applicant for SL-100 ND:YAG LASER FOR PALLIATION OF GASTRO. MALI?

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

What is the FDA product code for SL-100 ND:YAG LASER FOR PALLIATION OF GASTRO. MALI?

The FDA product code for SL-100 ND:YAG LASER FOR PALLIATION OF GASTRO. MALI is LNK.

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Other records listing Medical Energy, 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.

K041419LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEMK871512SL-100 ND:YAG LASER FOR GYNECOLOGY USEK871511SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONSK871515SL-100 ND:YAG LASER FOR GASTROINTESTINAL BLEEDINGK871514SL-100 ND:YAG LASER FOR RECTAL PATHO. & HEMORRHOIDK871516SL-100 ND:YAG LASER FOR UROLOGIC SURGERY

View all 7 devices →

Related Devices (Code: LNK)

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.

K925395TECHNOMED PULSOLITH 4000 LASER SYSTEMTeknomed, Inc.K901723MDL-2000 LASERTRIPTERCandela Laser Corp.K874255ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.Minnesota Laser Corp.K874253ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.Minnesota Laser Corp.K880256MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USESharplan Lasers, Inc.K880193MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USESharplan Lasers, Inc.

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.

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