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FDA 510(k)

COOLTOUCH

K-Number: K103338 · 2011-11-01

ApplicantNew Star Lasers, Inc.
Decision Date2011-11-01
Product CodePDZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COOLTOUCH 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 2011-11-01 under 510(k) number K103338. The device is classified under product code PDZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOLTOUCH?

COOLTOUCH is a medical device that received FDA 510(k) clearance on 2011-11-01. The listed applicant is New Star Lasers, Inc.. The 510(k) number is K103338.

When did COOLTOUCH receive FDA 510(k) clearance?

COOLTOUCH received FDA 510(k) clearance on 2011-11-01, under 510(k) number K103338.

Who is the listed applicant for COOLTOUCH?

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 COOLTOUCH?

The FDA product code for COOLTOUCH is PDZ.

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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.

K101783COOLTOUCH MODEL CT3PZ, COOLTOUCH CT3 PLUS COOLBREEZEK092964COOLTOUCH VARIA ND:YAG LASER SYSTEMK090410COOLTOUCH THERMAL SENSING HANDPIECE ACCESSORYK081628MODIFICATION TO COOLTOUCH, MODELS LC225 AND COOLLIPOK080163COOLTOUCH MODELS LC215 AND COOLLIPOK072751COOLTOUCH MODELS NS 160 AND LC215 COOLIPO

View all 27 devices →

Related Devices (Code: PDZ)

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.

K253960Medicell Mycosis Laser (MCML24004)Medicell Healthcare Co.,LTDK241116Onycho Laser VTerasysd&C, Inc.K211265TFX-LT2000 Therapy LightToefx, Inc.K221363AF LaserShenB Co., Ltd.K190034REMY Medical Therapy Laser SystemFootdocprenur, LLCK153164LunulaLaserErchonia Medical, 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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