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Every article here, written from manufacturer documents and regulatory records.
Potenza Insulated vs Non-Insulated Tips: What the FDA Clearance Does and Doesn't Say
Potenza's FDA clearance summary is specific about one thing: tip count. Six electrode tip types for the motorized handpiece, three needle tip types for the…
InMode Forma vs MiniFX: What 50W vs 25W Means in the FDA Filing
The comparison table for non-invasive applicators in FDA 510(k) K210492 lists, handpiece by handpiece, the maximum radiofrequency output each one draws when…
Pico Toning Results: What Three Picosecond Laser Studies Actually Measured
Two time values sit inside the papers behind picotoning. One is a pulse width of 750 picoseconds. The other is the stress relaxation time of a melanin…
Ultherapy Depths Explained: 1.5, 3.0 and 4.5 mm and What the 8 mm Screen Shows
The FDA 510(k) summary for K180623 lists the energy of a single Ulthera pulse at under 2 joules. The same filing places the device in Class II under 21 CFR…
Volnewmer vs Thermage: 115 W vs 400 W at the Same 6.78 MHz
Four hundred watts and 115 watts. Those two figures sit side by side in the comparison table of FDA 510(k) summary K240248, one column for the predicate…
RevLite SI Melasma Relapse Rate: Why Studies Report Both 18.8% and 50%
A randomized, double-blind, split-face trial in 16 Asian women treated one side of the same face with a 1064nm picosecond laser and the other with Revlite…
Shaver Head Replacement Interval: Check the Part Number, Not the Brand
Philips publishes six months, twelve months and two years at the same time. Reading the official pages shows why the brand is the wrong unit for this question.
Waterproof vs IP Rating: What IPX7 Actually Means for a Shaver or Toothbrush
The Braun Series 9 Pro Plus page states waterproofing outright and prints no IP code. Reading the standard alongside the product page shows why those are two different kinds of information.
At-Home IPL Hair Removal: How the US FDA Record Classifies These Devices
Open the current 510(k) record for Philips Lumea and one line stands out: the product code. Here is what that code establishes, and what it does not.
LED Face Mask Wrinkle Claims: Where the FDA Product Code Puts Them
At-home LED masks and IPL hair removal devices share a regulation number in the United States. What separates them is the product code beneath it — the part marketing usually leaves out.
Monopolar RF Devices Compared: Why Thermage, Volnewmer and Oligio All Use 6.78 MHz
Thermage FLX and Korea's Volnewmer list the same radiofrequency. Reading the 510(k) records and manufacturer specifications shows where the shared number stops explaining anything.
Volnewmer vs Oligio: What Their FDA Filings Share and Where They Differ
Wontech's Oligio and Classys's Volnewmer both run 6.78MHz monopolar radiofrequency, and both cite the same predicate device in their US 510(k) filings. Line…