Cutera, Inc.
Cutera, Inc. holds FDA 510(k) medical device clearances, first cleared 2004, most recent 2025, with 1 FDA device recall on record.
Top product codes for Cutera, Inc.
FDA recalls by Cutera, Inc.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Cutera, Inc.
- K251149 — AviClear Laser System
- K233237 — xeo+ Family
- K230660 — AviClear Laser System
- K223110 — truSculpt iD
- K221407 — truSculpt iD
- K213461 — AviClear Laser System
- K182997 — enlighten III Laser System
- K180709 — truSculpt RF Device; truSculpt; truSculpt 3D
- K172077 — Cutera enlighten III Laser System
- K172004 — truSculpt
- K170936 — Cutera enlighten III Laser System
- K162512 — truSculpt
- K160488 — Cutera enlighten III Laser System
- K153671 — Family of CoolGlide Aesthetic Lasers
- K140727 — CUTERA PICOSECOND LASER SYSTEM
- K133739 — TRUSCULPT
- K133945 — CUTERA PICOSECOND LASER SYSTEM
- K132185 — FAMILY OF COOLGLIDE AESTHETIC LASERS
- K122493 — GENESISPLUS
- K122389 — TRUSCULPT
- K102954 — CUTERA QSWITCH LASER SYSTEM
- K103626 — CUTERA GENESISPLUS LASER SYSTEM
- K092195 — CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)
- K080530 — MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE
- K080300 — CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)
- K063867 — CUTERA ER:YSGG LASER HANDPIECE
- K070138 — CUTERA ER:YAG LASER HANDPIECE
- K050047 — CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY
- K050679 — CUTERA SOLERA OPUS AESTHETIC PRODUCT
- K050069 — CUTERA FLASHLAMP TABLETOP AESTHETIC PRODUCT
- K042165 — CUTERA TABLETOP AESTHETIC PRODUCT
Data sourced from openFDA. This site is unofficial and independent of the FDA.