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

Palo Alto, CA, US

SCITON, INC. appears in FDA device records in Palo Alto, CA. FDA records list 23 510(k) clearances between and , no PMA records and one registered establishment. 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
23
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 23 510(k) clearances for Sciton, Inc. between 2000 and 2025. The busiest year on record is 2000, with 2. The most recent is 2025, with 1.

Clearances by year, as a table
510(k) clearance decisions for Sciton, Inc., by decision year
YearClearances
20002
20012
20022
20032
20042
20061
20071
20081
20112
20131
20182
20191
20222
20241
20251
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K251077JOULE 1064nm System and AccessoriesGEXSubstantially Equivalent
K222958mJOULE RF System and AccessoriesGEISubstantially Equivalent
K213761Joule diVa SystemGEXSubstantially Equivalent
K213350mJOULE System and AccessoriesGEXSubstantially Equivalent
K182173Joule SystemGEXSubstantially Equivalent
K180508JOULE SYSTEMGEXSubstantially Equivalent
K173285JOULE SYSTEMGEXSubstantially Equivalent
K122567JOULE 810/940/980 MULTI-PLATFORM SYSTEMGEXSubstantially Equivalent
K111483JOULE CLEARSENSE LASER SYSTEMPDZSubstantially Equivalent
K101916JOULE MULTI-PLATFORM SYSTEMGEXSubstantially Equivalent
K081352PROFILE MULTI-PLATFORM SYSTEMGEXSubstantially Equivalent
K070388PROFILE MULTI-PLATFORM SYSTEMGEXSubstantially Equivalent
K060033PROFILE MULTI-PLATFORM SYSTEMGEXSubstantially Equivalent
K040005PROFILE 2000/3000 LASER SYSTEMGEXSubstantially Equivalent
K032459PROFILE 1320 LASER SYSTEMGEXSubstantially Equivalent
K032460PROFILE BBL SYSTEMGEXSubstantially Equivalent
K023881PROFILE 1064 LASER SYSTEMGEXSubstantially Equivalent
K022466PROFILE 1320 LASER SYSTEMGEXSubstantially Equivalent
K022381PROFILE 1320 LASER SYSTEMGEXSubstantially Equivalent
K012552SCITON IMAGE HAIR REMOVAL LASERGEXSubstantially Equivalent
K010285CONTOUR PROFILE LASERGEXSubstantially Equivalent
K002853SCITON IMAGE HAIR REMOVAL LASERGEXSubstantially Equivalent
K003046IMAGE VASCULAR LASERGEXSubstantially Equivalent

Registered establishments

FDA registered establishments for Sciton, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
29536963001415984SCITON, INC.925 COMMERCIAL STREET, Palo Alto, CA 94303 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