FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US— 510(k) K101490

Name: FDA 510(k) clearance K101490
Creator: U.S. Food and Drug Administration
Published: 2010-09-08

Substantially Equivalent

Thermage, Inc.

FDA 510(k) clearance K101490 for FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US, Substantially Equivalent on 2010-09-08. Applicant: Thermage, Inc.. Device class: 2.

Clearance details

Applicant: Thermage, Inc.
Product code: Code ONG
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2010-06-01
Decision date: 2010-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hayward, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K101490

K-number listed on FDA's recall record

Z-1463-2014 — FRAXEL DUAL 1550/1927 Laser System, (FRAXEL SR 1500 DUAL Laser System), for dermatological procedures.Class II·Terminated·Solta Medical, Inc.·20140320

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101490.

Data sourced from openFDA. This site is unofficial and independent of the FDA.