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FDA 510(k)

SCALAR WAVE LASER SYSTEM

K-Number: K091158 · 2009-08-10

ApplicantStellar Lasers
Decision Date2009-08-10
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

SCALAR WAVE LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Stellar Lasers. It received FDA 510(k) clearance on 2009-08-10 under 510(k) number K091158. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCALAR WAVE LASER SYSTEM?

SCALAR WAVE LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2009-08-10. The listed applicant is Stellar Lasers. The 510(k) number is K091158.

When did SCALAR WAVE LASER SYSTEM receive FDA 510(k) clearance?

SCALAR WAVE LASER SYSTEM received FDA 510(k) clearance on 2009-08-10, under 510(k) number K091158.

Who is the listed applicant for SCALAR WAVE LASER SYSTEM?

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

What is the FDA product code for SCALAR WAVE LASER SYSTEM?

The FDA product code for SCALAR WAVE LASER SYSTEM is ILY.

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Related Devices (Code: ILY)

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.

K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)Wuhan PHOMED Technology Company , Ltd.K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)Gigaalaser Company , Ltd.K231997SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)Cure Point Therapeutics, Inc.K223642LED Lip Perfector, model: ZC-05Light Tree Ventures Europe B.V.K221189OLIZ LTB-1000ALtbio Co., Ltd.K213524CytonPro-5000Cytonsys, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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