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

Brisbane, CA, US

CUTERA, INC. appears in FDA device records in Brisbane, CA. FDA records list 31 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
31
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 31 510(k) clearances for Cutera Inc between 2004 and 2025. The busiest year on record is 2005, with 3. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Cutera Inc, by decision year
YearClearances
20041
20053
20072
20082
20091
20112
20121
20132
20143
20163
20173
20182
20223
20232
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K251149AviClear Laser SystemGEXSubstantially Equivalent
K233237xeo+ FamilyGEXSubstantially Equivalent
K230660AviClear Laser SystemGEXSubstantially Equivalent
K223110truSculpt iDGEISubstantially Equivalent
K221407truSculpt iDGEISubstantially Equivalent
K213461AviClear Laser SystemGEXSubstantially Equivalent
K182997enlighten III Laser SystemGEXSubstantially Equivalent
K180709truSculpt RF Device; truSculpt; truSculpt 3DPBXSubstantially Equivalent
K172077Cutera enlighten III Laser SystemGEXSubstantially Equivalent
K172004truSculptPBXSubstantially Equivalent
K170936Cutera enlighten III Laser SystemGEXSubstantially Equivalent
K162512truSculptPBXSubstantially Equivalent
K160488Cutera enlighten III Laser SystemGEXSubstantially Equivalent
K153671Family of CoolGlide Aesthetic LasersGEXSubstantially Equivalent
K140727CUTERA PICOSECOND LASER SYSTEMGEXSubstantially Equivalent
K133739TRUSCULPTPBXSubstantially Equivalent
K133945CUTERA PICOSECOND LASER SYSTEMGEXSubstantially Equivalent
K132185FAMILY OF COOLGLIDE AESTHETIC LASERSGEXSubstantially Equivalent
K122493GENESISPLUSGEXSubstantially Equivalent
K122389TRUSCULPTPBXSubstantially Equivalent
K102954CUTERA QSWITCH LASER SYSTEMGEXSubstantially Equivalent
K103626CUTERA GENESISPLUS LASER SYSTEMPDZSubstantially Equivalent
K092195CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)NUVSubstantially Equivalent
K080530MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECEGEXSubstantially Equivalent
K080300CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)NUVSubstantially Equivalent
K070138CUTERA ER:YAG LASER HANDPIECEGEXSubstantially Equivalent
K063867CUTERA ER:YSGG LASER HANDPIECEGEXSubstantially Equivalent
K050679CUTERA SOLERA OPUS AESTHETIC PRODUCTGEXSubstantially Equivalent
K050047CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILYGEXSubstantially Equivalent
K050069CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCTGEXSubstantially Equivalent
K042165CUTERA TABLETOP AESTHETIC PRODUCTILYSubstantially Equivalent

Registered establishments

FDA registered establishments for Cutera Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
29543543002900199CUTERA, INC.3240 BAYSHORE BLVD, BRISBANE, CA 94005 US2026

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

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0427-2014Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distributed by Cutera, Inc., Brisbane, CA The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite. The truSculpt infrared (optional) and RF energies are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.Cutera received two adverse events associated with the edge of the electrode, when it was pressed against neck skin over the thyroid cartilage and due to the absence of adequate underlying conductive tissue, increased skin heating occurred. Both patients developed linear welts and blisters consistent with partial thickness thermal burns to the skin.Class IITerminated
Z-0329-2011Titan XL Handpiece Infrared Therapeutic Heating Lamp, Manufactured by Cutera Inc, Brisbane, CA Infrared therapeutic heating lamp, intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness.Risk of burns-- under certain conditions, devices containing a gold plated end block could produce energy above what is stated on the device setting.Terminated

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