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FDA 510(k)

OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL

K-Number: K870505 · 1987-08-07

ApplicantTrimedyne, Inc.
Decision Date1987-08-07
Product CodeLLO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL is the device name listed in this FDA 510(k) record. The listed applicant is Trimedyne, Inc.. It received FDA 510(k) clearance on 1987-08-07 under 510(k) number K870505. The device is classified under product code LLO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL?

OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL is a medical device that received FDA 510(k) clearance on 1987-08-07. The listed applicant is Trimedyne, Inc.. The 510(k) number is K870505.

When did OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL receive FDA 510(k) clearance?

OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL received FDA 510(k) clearance on 1987-08-07, under 510(k) number K870505.

Who is the listed applicant for OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL?

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

What is the FDA product code for OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL?

The FDA product code for OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL is LLO.

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Other records listing Trimedyne, 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.

K053457VAPORMAX IIK050412VAPORMAXK043012OMNIPULSE MINI, MODEL 2120K041660TRIMEDYNE HOLMIUM LASER SYSTEMSK022655TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATHK013974RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-A

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Related Devices (Code: LLO)

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.

K884815SLT CLMD CONTACT LASERSurgical Laser Technologies, Inc.K881499SURGILASE YAG 100 FOR GYNECOLOGY USESurgilase, Inc.K880592LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USELaser Peripherals, LLCK880170MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONSCooper Lasersonics, Inc.K874254ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONSMinnesota Laser Corp.K875104SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USELaserguide

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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