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FDA 510(k)

SOFTLIGHT Q-SWITCHED (ND:YAG) LASER

K-Number: K971207 · 1998-05-13

ApplicantThermolase Corp.
Decision Date1998-05-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SOFTLIGHT Q-SWITCHED (ND:YAG) LASER is the device name listed in this FDA 510(k) record. The listed applicant is Thermolase Corp.. It received FDA 510(k) clearance on 1998-05-13 under 510(k) number K971207. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFTLIGHT Q-SWITCHED (ND:YAG) LASER?

SOFTLIGHT Q-SWITCHED (ND:YAG) LASER is a medical device that received FDA 510(k) clearance on 1998-05-13. The listed applicant is Thermolase Corp.. The 510(k) number is K971207.

When did SOFTLIGHT Q-SWITCHED (ND:YAG) LASER receive FDA 510(k) clearance?

SOFTLIGHT Q-SWITCHED (ND:YAG) LASER received FDA 510(k) clearance on 1998-05-13, under 510(k) number K971207.

Who is the listed applicant for SOFTLIGHT Q-SWITCHED (ND:YAG) LASER?

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

What is the FDA product code for SOFTLIGHT Q-SWITCHED (ND:YAG) LASER?

The FDA product code for SOFTLIGHT Q-SWITCHED (ND:YAG) LASER is GEX. This falls under the Gastroenterology category.

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Other records listing Thermolase Corp. 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.

K993209SOFTLIGHT Q-SWITCHED ND: YAG LASER WITH OPTIONAL BEAM-SHRINKING HANDPIECE ACCESSORYK950019THERMOLASE LT-100 ND:YAG LASER HAIR REMOVAL SYSTEM; THERMOLASE LT-100;LT-100

Related Devices (Code: GEX)

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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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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