K-number	K243044
Device name	Alma Harmony
Applicant	Alma Lasers, Inc.
Product code	GEX
Device class	Class II
Decision date	Apr 11, 2025
Decision	Substantially Equivalent
Regulation	878.4810

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The Alma Harmony is a multi-wavelength laser surgical instrument for dermatology and aesthetic surgery. It operates in 1064nm, 532nm, and diode modes to treat unwanted hair, skin resurfacing, pigmented lesions, tattoos, vascular lesions, wrinkles, and soft tissue procedures across multiple skin types.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

Alma Harmony

Everything you need for a 510(k) submission. Nothing you don't.