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FDA 510(k)

CILAS MODEL YM101

K-Number: K852761 · 1985-11-14

ApplicantInframed, Inc.
Decision Date1985-11-14
Product CodeLLO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

CILAS MODEL YM101 is the device name listed in this FDA 510(k) record. The listed applicant is Inframed, Inc.. It received FDA 510(k) clearance on 1985-11-14 under 510(k) number K852761. 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 CILAS MODEL YM101?

CILAS MODEL YM101 is a medical device that received FDA 510(k) clearance on 1985-11-14. The listed applicant is Inframed, Inc.. The 510(k) number is K852761.

When did CILAS MODEL YM101 receive FDA 510(k) clearance?

CILAS MODEL YM101 received FDA 510(k) clearance on 1985-11-14, under 510(k) number K852761.

Who is the listed applicant for CILAS MODEL YM101?

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

What is the FDA product code for CILAS MODEL YM101?

The FDA product code for CILAS MODEL YM101 is LLO.

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.

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Other records listing Inframed, 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.

K864610CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USEK844178MODEL TT25RF

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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