Laser Hair Therapy— 510(k) K183329
Substantially EquivalentOmm Imports, Inc. D/B/A Zero Gravity
FDA 510(k) clearance K183329 for Laser Hair Therapy, Substantially Equivalent on 2019-01-16. Applicant: Omm Imports, Inc. D/B/A Zero Gravity. Device class: 2.
Clearance details
- Applicant
- Omm Imports, Inc. D/B/A Zero Gravity
- Product code
- Code OAP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5500
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hallandale, FL, US
Recent devices under product code OAP
view all- K261675 — CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D)
- K261253 — Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5)
- K253231 — Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)
- K260899 — Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)
- K251684 — Alma TED+ System
More clearances from Omm Imports, Inc. D/B/A Zero Gravity
view allRecalls naming K183329
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183329.
Data sourced from openFDA. This site is unofficial and independent of the FDA.