510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K101490Substantially Equivalent

Fraxel Re:store Dual Laser System: Model, Mc-Sys-Sr1500-D-US

Solta Medical, Inc., Hayward CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101490 is the FDA 510(k) clearance record for FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US, a class II device, cleared for Thermage, Inc. on under FDA product code ONG (Powered Laser Surgical Instrument With MicrobeamFractional Output). FDA's definition for product code ONG reads: "A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. The laser output is in form of tiny beams in micro range. Typically, indicated to be used in...". FDA records list 37 510(k) clearances for Solta Medical, Inc., from to . As of , FDA records show 2 recalls naming K101490.

Clearance record

Decision date
Received
(99 days to decision)
Product code
ONG Powered Laser Surgical Instrument With MicrobeamFractional Output
Regulation
21 CFR 878.4810
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Thermage, Inc. 25881 Industrial Blvd., Hayward CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ONG

Trailing 12 months

FDA records hold no clearances under product code ONG in the trailing twelve months.

FDA records show no clearances under product code ONG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ONG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260