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FDA 510(k)

DERMATHERM 100

K-Number: K980607 · 1998-04-03

ApplicantNew Star Lasers, Inc.
Decision Date1998-04-03
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DERMATHERM 100 is the device name listed in this FDA 510(k) record. The listed applicant is New Star Lasers, Inc.. It received FDA 510(k) clearance on 1998-04-03 under 510(k) number K980607. 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 DERMATHERM 100?

DERMATHERM 100 is a medical device that received FDA 510(k) clearance on 1998-04-03. The listed applicant is New Star Lasers, Inc.. The 510(k) number is K980607.

When did DERMATHERM 100 receive FDA 510(k) clearance?

DERMATHERM 100 received FDA 510(k) clearance on 1998-04-03, under 510(k) number K980607.

Who is the listed applicant for DERMATHERM 100?

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

What is the FDA product code for DERMATHERM 100?

The FDA product code for DERMATHERM 100 is ILY.

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Other records listing New Star Lasers, 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.

K103338COOLTOUCHK101783COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZEK092964COOLTOUCH VARIA ND:YAG LASER SYSTEMK090410COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORYK081628MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPOK080163COOLTOUCH MODELS LC215 AND COOLLIPO

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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

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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