Cleared Traditional

ALMA LASERS FAMILY OF PIXEL RF TIPS (K121150) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K121150 · Alma Lasers, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
158d
Days
Class 2
Risk

K121150 is an FDA 510(k) clearance for the ALMA LASERS FAMILY OF PIXEL RF TIPS. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Alma Lasers, Inc. (Buffalo Grove, US). The FDA issued a Cleared decision on September 21, 2012 after a review of 158 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Alma Lasers, Inc. devices

Submission Details

510(k) Number K121150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2012
Decision Date September 21, 2012
Days to Decision 158 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 115d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 621
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K121150.
LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER
K130744 · Covidien · Apr 2013
CAIMAN SEAL AND CUT TECHNOLOGY
K130596 · Aesculap, Inc. · Mar 2013
PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR
K113380 · Medtronic, Inc. · Nov 2012
AQUAMANTRYS3 BSC 9.1S
K121290 · Medtronic, Inc. · Jun 2012
AQUAMANTYS3 9.5 XL BIPOLAR SEALER
K120537 · Medtronic, Inc. · May 2012
LEVEEN SUPERSLIM NEEDLE ELECTRODE
K113090 · Boston Scientific Corporation · Mar 2012