510(k) clearances

Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap

Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC · Physical Medicine

K240456Substantially EquivalentSpecialOAP
Open FDA's page for this record
Third party flag
N
City
Miami
Advisory committee description
Physical Medicine
Address 1
1499 NW 79th Ave.
Statement or summary
Summary
Product code
OAP
Zip code
33126
Applicant
Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC
Decision date
2024-05-22
Decision code
SESE
Country code
US
Device name
Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap
Advisory committee
PM
Contact
Ira Nusbaum
K number
K240456
State
FL
Date received
2024-02-15
Review advisory committee
SU
Postal code
33126
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Laser, Comb, Hair
Medical specialty description
Physical Medicine
Regulation number
890.5500
Device class
2
Registration number
3012234230, 3010027944, 3013472744, 3010724743, 3006546131, 3013591868, 3038373471, 3008393409, 3012327767, 2248223, 3016661372, 3010321647, 3023876581, 3015060197, 3043149902, 3013553501, 3006206425, 3009765778, 3015313684, 3042228064, 3016245372, 3033905868, 3031980484, 3015191560, 3020900954, 3043140693, 3033590685, 3006368133, 3014755446, 3008295459, 3013519365, 3010123655, 3013387006, 3043012240, 3015415349, 3033847811, 3013503862, 3014737458, 3018949797, 3019015047 +36 more
FEI number
3012234230, 3010027944, 3013472744, 3010724743, 3006546131, 3013591868, 3038373471, 3008393409, 3012327767, 3016661372, 3010321647, 3023876581, 3015060197, 3043149902, 3013553501, 3006206425, 3009765778, 3015313684, 3042228064, 3016245372, 3033905868, 3031980484, 3015191560, 3020900954, 3043140693, 3033590685, 3006368133, 3014755446, 3008295459, 3013519365, 3010123655, 3013387006, 3043012240, 3015415349, 3033847811, 3013503862, 3014737458, 3018949797, 3019015047, 3008699663 +36 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.