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FDA 510(k)

LASERSAFE PERSONNEL AND PATIENT SHIELDS

K-Number: K852405 · 1985-10-01

ApplicantLasersafe, Inc.
Decision Date1985-10-01
Product CodeCAI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

LASERSAFE PERSONNEL AND PATIENT SHIELDS is the device name listed in this FDA 510(k) record. The listed applicant is Lasersafe, Inc.. It received FDA 510(k) clearance on 1985-10-01 under 510(k) number K852405. The device is classified under product code CAI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LASERSAFE PERSONNEL AND PATIENT SHIELDS?

LASERSAFE PERSONNEL AND PATIENT SHIELDS is a medical device that received FDA 510(k) clearance on 1985-10-01. The listed applicant is Lasersafe, Inc.. The 510(k) number is K852405.

When did LASERSAFE PERSONNEL AND PATIENT SHIELDS receive FDA 510(k) clearance?

LASERSAFE PERSONNEL AND PATIENT SHIELDS received FDA 510(k) clearance on 1985-10-01, under 510(k) number K852405.

Who is the listed applicant for LASERSAFE PERSONNEL AND PATIENT SHIELDS?

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

What is the FDA product code for LASERSAFE PERSONNEL AND PATIENT SHIELDS?

The FDA product code for LASERSAFE PERSONNEL AND PATIENT SHIELDS is CAI.

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 Lasersafe, 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.

K854266STERILE LASER RESISTANT SURGICAL FIELD DRAPEK852404LASERSAFE EYE SHIELDS

Related Devices (Code: CAI)

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.

K954480CONDENSATE COLLECTION KITNova-VentrxK953787UNICOR, INC. ADULT ANESTHESIA BREATHING CIRCUITUnicor, Inc.K953788UNICOR, INC. GAS SAMPLING LINES & CONNECTORSUnicor, Inc.K952016PRIMA PEDIATRIC GAS SAMPLING CIRCUITSPrima, Inc.K952018PRIMA COAXIAL CIRCUITSPrima, Inc.K952020PRIMA PEDIATRIC ANESTHESIA CIRCUITSPrima, 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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