510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Alma Lasers Ltd.

CAESAREA Northern, IL

ALMA LASERS LTD. appears in FDA device records in CAESAREA Northern, IL. FDA records list 34 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
34
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 34 510(k) clearances for Alma Lasers Ltd. between 2007 and 2026. The busiest year on record is 2008, with 4. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Alma Lasers Ltd., by decision year
YearClearances
20072
20084
20093
20101
20113
20122
20142
20161
20173
20182
20212
20222
20232
20241
20253
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K251684Alma TED+ SystemOAPSubstantially Equivalent
K250071Alma FemiLift Pixel CO2 Laser System, Delivery Devices and AccessoriesGEXSubstantially Equivalent
K251230The Alma Hybrid Laser SystemGEXSubstantially Equivalent
K243044Alma HarmonyGEXSubstantially Equivalent
K233024Alma HarmonyGEXSubstantially Equivalent
K230308Alma HarmonyGEXSubstantially Equivalent
K230371The Alma Soprano TitaniumGEXSubstantially Equivalent
K222064The Alma Soprano TitaniumGEXSubstantially Equivalent
K212073Alma Diode Tabletop LaserGEXSubstantially Equivalent
K201520The Alma Opus System, Colibri Applicator and TipsGEISubstantially Equivalent
K203441The Alma Hybrid Laser SystemGEXSubstantially Equivalent
K181298Harmony XL Multi-Application PlatformONFSubstantially Equivalent
K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser ModulesGEXSubstantially Equivalent
K171242Alma LipoFlow SystemMUUSubstantially Equivalent
K170850Alma QGEXSubstantially Equivalent
K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand pieceGEXSubstantially Equivalent
K160075Accent XLIMISubstantially Equivalent
K140009SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORMGEXSubstantially Equivalent
K140005ALMA DIODE TABLETOP LASERGEXSubstantially Equivalent
K121150ALMA LASERS FAMILY OF PIXEL RF TIPSGEISubstantially Equivalent
K113810MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULESPDZSubstantially Equivalent
K112031ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATIONGEXSubstantially Equivalent
K101147MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMNUVSubstantially Equivalent
K103501ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIESGEXSubstantially Equivalent
K102716MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMSGEXSubstantially Equivalent
K090571ALMA LASERS ALEX755 MODULEGEXSubstantially Equivalent
K083848ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORMGEXSubstantially Equivalent
K082622ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULENUVSubstantially Equivalent
K080463ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIESGEXSubstantially Equivalent
K072182ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2940, 1060GEXSubstantially Equivalent
K072564ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORMGEXSubstantially Equivalent
K080318ALMA LASER NIR MODULEILYSubstantially Equivalent
K072699ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMS, MODELS: ACCENT, ACCENT XLGEISubstantially Equivalent
K070004ACCENTGEISubstantially Equivalent

Registered establishments

FDA registered establishments for Alma Lasers Ltd., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30041679693004167969ALMA LASERS LTD.18 Haharash Street, CAESAREA Northern 3079895 IL2026and 8 more, listed in full below
30044506613004450661ALMA LASERS, INC.485 Half Day Rd Ste 100, BUFFALO GROVE, IL 60089 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain