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FDA 510(k)

FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500

K-Number: K091420 · 2009-10-14

ApplicantSolta Medical, Inc.
Decision Date2009-10-14
Product CodeONG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500 is the device name listed in this FDA 510(k) record. The listed applicant is Solta Medical, Inc.. It received FDA 510(k) clearance on 2009-10-14 under 510(k) number K091420. The device is classified under product code ONG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500?

FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500 is a medical device that received FDA 510(k) clearance on 2009-10-14. The listed applicant is Solta Medical, Inc.. The 510(k) number is K091420.

When did FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500 receive FDA 510(k) clearance?

FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500 received FDA 510(k) clearance on 2009-10-14, under 510(k) number K091420.

Who is the listed applicant for FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500?

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

What is the FDA product code for FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500?

The FDA product code for FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500 is ONG.

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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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