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BIOPHOTAS, INC.

USA · Tustin

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Australia, Israel — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

5listed device types

Class I 0Class II 5Class III 0

plus 4 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

IIa 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States4 registration records, 6 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: BIOPHOTAS, INC. · BIOPHOTAS, INC

FDA 510(k) clearances by year

12013 · K122237

12014 · K131113

12016 · K152280

12017 · K171323

12021 · K211038

12023 · K232977

FDA listed device types

Lamp, Infrared, Therapeutic Heating 1Light Based Over The Counter Wrinkle Reduction 1Fat Reducing Low Level Laser 1Over-The-Counter Powered Light Based Laser For Acne 1Laser, Comb, Hair 1

Market	Identifier	Name	Class / date
US	K232977	Biophotas Celluma CONTOUR	2023-11-21
US	K211038	Biophotas Celluma RESTORE	2021-06-29
US	K171323	BIOPHOTAS CELLUMA3	2017-09-01
BR	80409959003	CELLUMA	Class II

BIOPHOTAS, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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